HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Report
- Report Number
- 3007042319-2022-08456
- Event Type
- Death
- Date Received
- December 12, 2022
- Date of Event
- December 6, 2022
- Report Date
- August 21, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000017
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420, CATALOG #: 1420, EXPIRATION DATE: 30-SEP-2018, SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 30-SEP-2017, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420, CATALOG #: 1420, EXPIRATION DATE: 31-DEC-2022, SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUTION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 20-DEC-2021, DEVICE EVALUATED BY MFR: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420, CATALOG #: 1420, EXPIRATION DATE: 30-SEP-2018, SERIAL #: (B)(4), UDI #: (B)(4), DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATED: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 30-SEP-2017, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ DRIVELINE BOOT COVER, MODEL #: 1175, CATALOG #: 1175, DEVICE AVAILABOR FOR EVALUATION: NO, DEVICE EVALUATED: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, LABLED FOR SINGLE USE: NO, (B)(4). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL EVENT DETAILS. THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A MEDWATCH REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT. MEDWATCH DATABASE REPORT NUMBER: (B)(4). F1 USER FACILITY (B)(6) F2 UF/IMPORTER REPORT NUMBER: (B)(4) F3 USER FACILITY NAME/ADDRESS: (B)(6) F4 CONTACT PERSON: (B)(6) F5 PHONE NUMBER: (B)(6) F6 DATE USER FACILITY BECAME AWARE OF THE EVENT: 01-JAN-2023 F7 TYPE OF REPORT: ADVERSE EVENT AND PRODUCT PROBLEM F8 DATE OF THIS REPORT: 01-JAN-2023 F9 APPROXIMATE AGE OF DEVICE: 5 YEARS F10 EVENT PROBLEM CODES: F11 REPORT SENT TO FDA: YES F12 LOCATION WHERE EVENT OCCURRED: HOME F13 REPORT SENT TO MANUFACTURER: YES F14 MANUFACTURER NAME AND ADDRESS MFR. NAME: HEARTWARE INC ADDL: 14400 NW 60TH AVE CITY: MIAMI LAKES STATE: FL ZIP: 33014 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTIONS. B5 DESCRIBE EVENT OR PROBLEM, E4 EMAIL AND (B)(6), H6 CODES WERE PRE VIOUSLY OMITTED. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6), H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705, A0708 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE DRIVELINE BOOT COVER LOT NUMBER. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ DRIVELINE BOOT COVER D4: SERIAL OR LOT#: R020408 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: (B)(6), THE ASSOCIATED DRIVELINE BOOT COVER (LOT R020408), AND THREE (3) CONTROLLERS ((B)(6)), AND WERE NOT RETURNED FOR EVALUATION. THERE WAS NO EVIDENCE THAT THE DRIVELINE BOOT COVER (LOT R020408) ASSOCIATED WITH (B)(6) HAD PREVIOUSLY BEEN SERVICED. A REVIEW OF THE DRIVELINE COVER¿S INSPECTION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER IN USE AT THE TIME OF THE REPORTED EVENT. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) REVEALED ONE (1) CONTROLLER POWER-UP EVENT, WITH AN ASSOCIATED MOTOR START EVENT, LOGGED ON 06-DEC-2022 AT 16:15:27. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT A POWER ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 28% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR ELEVEN (11) SECONDS. A CONTROLLER FAULT ALARM WAS THEN LOGGED AT 16:51:52, INDICATING AN ISSUE WITH THE INTERNAL BATTERY. IN ADDITION, LOG FILES REVEALED THAT THE CONTROLLER HAD BEEN IN USE FOR MORE THAN TWO (2) YEARS. A VAD DISCONNECT WAS LOGGED AT 16:58:35, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. AN ELECTRICAL FAULT ALARM WAS THEN RECORDED AT 17:08:54, INDICATING THAT THE FRONT STATOR WAS NOT CONNECTED, RESULTING IN THE PUMP RUNNING ON A SINGLE STATOR (REAR STATOR ONLY). A VAD STOPPED ALARM WAS SUBSEQUENTLY LOGGED AT 17:09:00 DUE TO THE MOTOR STATORS FAILING. ANOTHER VAD DISCONNECT ALARM WAS RECORDED AT 17:09:01, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. REVIEW OF THE AVAILABLE LOG FILES ASSOCIATED WITH (B)(6) REVEALED THAT THE CONTROLLER WAS NOT IN USE DURING THE REPORTED EVENT. CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED CONTROLLER FAULT ALARM, ELECTRICAL FAULT ALARM, AND CONTROLLER LOSS OF POWER EVENTS WERE CONFIRMED. NO CONTROLLER FAILED ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD; HOWEVER, IT IS LIKELY THAT THE OBSERVED CONTROLLER FAULT ALARM CORRESPONDS WITH THE REPORTED ¿CONTROLLER FAILED¿ EVENT. THE REPORTED DIFFICULTY REMOVING THE DRIVELINE COVER, DRIVELINE POOR MECHANICAL CONNECTION, AND DRIVELINE FOREIGN MATERIAL EVENTS COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. A POSSIBLE ROOT CAUSE OF THE CONTROLLER LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. A POSSIBLE ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, POTENTIALLY ASSOCIATED WITH THE REPORTED CONTROLLER EXCHANGES AND/OR A MARGINAL DRIVELINE CONNECTION. BASED ON RISK DOCUMENTATION AND THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE REPORTED ELECTRICAL FAULT ALARM AND THE REPORTED POOR MECHANICAL CONNECTION EVENT CAN BE ATTRIBUTED TO A MARGINAL DRIVELINE CONNECTION OR CONTAMINATION BY FOREIGN MATERIAL OF THE DRIVELINE CONNECTOR, LIKELY ASSOCIATED WITH THE REPORTED METAL PIECE ¿LODGED AROUND THE PINS IN THE DRIVELINE¿, WHICH MAY BE ATTRIBUTED BUT NOT LIMITED TO THE HANDLING OF THE DEVICE. APPLICABLE RISK DOCUMENTATION, EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES, AND THE AVAILABLE INFORMATION WERE CONSIDERED; POSSIBLE ROOT CAUSES OF THE CONTROLLER FAULT ALARM MAY BE ATTRIBUTED, BUT NOT LIMITED, TO A REDUCED CHARGE CAPACITY OF THE INTERNAL BATTERY AND/OR A FAULTY INTERNAL BATTERY CHARGER INTEGRATED CIRCUIT. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, A POSSIBLE ROOT CAUSE OF THE REPORTED DIFFICULTY REMOVING THE DRIVELINE COVER EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONTAMINATION/FOREIGN MATERIAL BETWEEN THE DRIVELINE CONNECTOR AND DRIVELINE COVER, LEACHING OF THE PLASTICIZER FROM THE MATERIAL, AND/OR DEGRADATION OF THE MATERIAL, RESULTING IN HARDENING. ADDITIONAL PRODUCTS: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C02, C04, C19 H6: FDA CONCLUSION CODE(S): D15, D1105 D4: SERIAL OR LOT#: (B)(6) H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL OR LOT#: (B)(6) H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL OR LOT#: (B)(6) H6: FDA METHOD CODE(S): B14, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR UPDATED INVESTIGATION RESULTS. REVISED PRODUCT EVENT SUMMARY: (B)(6), THE ASSOCIATED DRIVELINE BOOT COVER (LOT R020408), TWO (2) CONTROLLERS (B)(6), AND FIVE (5) BATTERIES (B)(6) WERE RETURNED FOR EVALUATION. ONE (1) CARRYING CASE (UNKNOWN LOT NUMBER) AND ONE (1) CONTROLLER (B)(6) WERE NOT RETURNED FOR EVALUATION. NO PERFORMANCE ALLEGATIONS WERE MADE AGAINST THE BATTERIES OR CARRYING CASE. REVIEW OF (B)(6) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THERE WAS NO EVIDENCE THAT THE DRIVELINE BOOT COVER (LOT R020408) OR DRIVELINE ASSOCIATED WITH (B)(6) HAD PREVIOUSLY BEEN SERVICED. A REVIEW OF THE DRIVELINE COVER¿S INSPECTION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. AS RECEIVED, (B)(6) WAS FULLY DEPLETED; HOWEVER, THE BATTERY WAS ABLE TO ADEQUATELY CHARGE DURING BENCH TESTING, AFTER WHICH THE BATTERY PERFORMED AS INTENDED. INTERNAL VISUAL INSPECTION OF (B)(6) DID NOT REVEAL ANY ANOMALIES. INTERNAL VISUAL INSPECTION OF (B)(6) REVEALED A SOLDER DEFECT WITHIN A CABLE WIRE CONNECTED TO THE PRINTED CIRCUIT (B)(6) (PCB). THE OBSERVED SOLDER DEFECT DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE; THE SOLDER CONNECTION TO THE PCB WAS FUNCTIONAL. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED SOLDER DEFECT WITH THE CABLE WIRE CAN BE ATTRIBUTED TO IMPROPER ASSEMBLY DURING THE MANUFACTURING PROCESS. VISUAL INSPECTION OF (B)(6) REVEALED THAT THE CONTROLLER'S PUMP CONNECTOR WAS DAMAGED; THE ARC-SHAPED METAL GUIDE WAS MISALIGNED. ADDITIONALLY, VISUAL INSPECTION REVEALED CONTAMINATION INSIDE THE PUMP CONNECTOR. INTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO ANOMALIES. AFTER THE PUMP CONNECTOR WAS REPLACED, THE CONTROLLER PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITHIN BOTH POWER PORT CONNECTORS, THE SERIAL PORT, AND THE PUMP CONNECTOR OF THE CONTROLLER. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND BOTH POWER PORTS. AN INTERNAL INSPECTION DID NOT REVEAL ANY EVIDENCE OF FLUID INGRESS. THE OBSERVED CONTAMINATION AND HAIRLINE CRACKS ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION WITHIN THE CONNECTORS OF BOTH CONTROLLERS CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALLS WITHIN THE BOUNDS OF THIS CAPA. VISUAL INSPECTION OF (B)(6) ALSO REVEALED THAT THE PUMP CONNECTOR WAS DAMAGED, WITH SEVERAL PINS BENT, ONE PIN BROKEN, AND THE HALF-MOON METAL ARC GUIDE MISSING. THE BENT PINS INDICATED THAT THE DRIVELINE CABLE WAS TWISTED OUT OF THE CONNECTOR WITH EXCESSIVE FORCE, DAMAGING THE INTERNAL COMPONENTS. PER THE INSTRUCTIONS FOR USE, TO REMOVE THE DRIVELINE FROM THE CONTROLLER, ONE SHOULD PLACE THEIR FINGERS OVER THE RINGED AREA OF THE DRIVELINE CONNECTOR AND PULL BACK TO RELEASE THE LOCKING MECHANISM, AND THE DRIVELINE SHOULD NEVER BE TWISTED. THE CONTROLLER PUMP CONNECTOR WAS REPLACED TO CONDUCT FUNCTIONAL TESTING. FUNCTIONAL TESTING REVEALED THAT THE NO POWER ALARM DID NOT SOUND AS LONG AS EXPECTED AND A CONTROLLER FAULT ALARM WAS TRIGGERED DURING TESTING, INDICATING AN ISSUE WITH THE INTERNAL BATTERY. INTERNAL INSPECTION REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY, WHICH POWERS THE NO POWER ALARM, WAS SLIGHTLY SWOLLEN. AFTER THE INTERNAL BATTERY WAS REPLACED, THE CONTROLLER PERFORMED AS INTENDED. VISUAL INSPECTION OF THE RETURNED SEGMENT OF THE DRIVELINE ASSOCIATED WITH (B)(6) REVEALED DAMAGE TO THE OUTER SHEATH, STRAIN RELIEF, AND INNER LUMEN, AS WELL AS YELLOWING OF THE OUTER SHEATH. ADDITIONALLY, BLACK TAPE WAS OBSERVED AT THE AREA WITH MISSING OUTER SHEATH, INDICATIVE OF A SELF-REPAIR OF THE DRIVELINE. FURTHER VISUAL INSPECTION OF THE DRIVELINE CONNECTOR REVEALED THE HALF-MOON PORTION OF A CONTROLLER'S PUMP CONNECTOR DETACHED AND TIGHTLY LODGED WITHIN THE DRIVELINE CONNECTOR. FUNCTIONAL TESTING OF THE DRIVELINE SEGMENT REVEALED THAT THE DRIVELINE MAINTAINED CONTINUITY ACROSS ALL WIRES ACROSS THE LENGTH OF THE RECEIVED SEGMENT. THE STUCK CONTROLLER COMPONENT DID NOT ALLOW THE DRIVELINE TO CONNECT SECURELY TO A TEST CONTROLLER PORT. ONCE THE LODGED COMPONENT WAS REMOVED, THE DRIVELINE FUNCTIONED AS INTENDED; THE DRIVELINE WAS ABLE TO CONNECT TO AND DISCONNECT FROM A TEST CONTROLLER AS EXPECTED. FAILURE ANALYSIS OF THE RETURNED DRIVELINE BOOT COVER REVEALED THAT THE DRIVELINE BOOT COVER PASSED FUNCTIONAL TESTING AND DIMENSIONAL VERIFICATION. EXTERNAL VISUAL INSPECTION REVEALED FOREIGN MATERIAL WITHIN THE RETURNED DRIVELINE BOOT COVER, LIKELY DUE TO HANDLING OF THE DEVICE. THE FOREIGN MATERIAL PRESENT DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. AS A RESULT, THE STUCK DRIVELINE BOOT COVER AND DRIVELINE EVENTS COULD NOT BE CONFIRMED DURING BENCH TESTING. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER IN USE AT THE TIME OF THE REPORTED EVENT. REVIEW OF THE EVENT LOG FILE ASSOCIATED WITH (B)(6) REVEALED ONE (1) CONTROLLER POWER-UP EVENT, WITH AN ASSOCIATED MOTOR START EVENT, LOGGED ON (B)(6) 2022 AT 16:15:27. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT A POWER ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 28% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR ELEVEN (11) SECONDS. A CONTROLLER FAULT ALARM WAS THEN LOGGED AT 16:51:52, INDICATING AN ISSUE WITH THE INTERNAL BATTERY. IN ADDITION, LOG FILES REVEALED THAT THE CONTROLLER HAD BEEN IN USE FOR MORE THAN TWO (2) YEARS. A VAD DISCONNECT WAS LOGGED AT 16:58:35, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. AN ELECTRICAL FAULT ALARM WAS THEN RECORDED AT 17:08:54, INDICATING THAT THE FRONT STATOR WAS NOT CONNECTED, RESULTING IN THE PUMP RUNNING ON A SINGLE STATOR (REAR STATOR ONLY). A VAD STOPPED ALARM WAS SUBSEQUENTLY LOGGED AT 17:09:00 DUE TO THE MOTOR STATORS FAILING. ANOTHER VAD DISCONNECT ALARM WAS RECORDED AT 17:09:01, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. REVIEW OF THE AVAILABLE LOG FILES ASSOCIATED WITH (B)(6) REVEALED THAT THE CONTROLLER WAS NOT IN USE DURING THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED TWO (2) VAD DISCONNECT ALARMS LOGGED ON (B)(6) ON 06/DEC/2022 AT 17:35:32 AND 17:56:44, INDICATING THAT THE DRIVELINE WAS NOT CONNECTED TO THE CONTROLLER WHEN THE BACK-UP CONTROLLER WAS POWERED ON. LOG FILES ASSOCIATED WITH (B)(6) WERE NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED DRIVELINE CONNECTOR DAMAGE/IMPROPER CONNECTION, CONTROLLER FAULT ALARM, ELECTRICAL FAULT ALARM, AND CONTRO LLER LOSS OF POWER EVENTS WERE CONFIRMED. NO CONTROLLER FAILED ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD; HOWEVER, IT IS LIKELY THAT THE OBSERVED CONTROLLER FAULT ALARM CORRESPONDS WITH THE REPORTED ¿CONTROLLER FAILED¿ EVENT. A POSSIBLE ROOT CAUSE OF THE CONTROLLER LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONTROLLER FAULT ALARM EVENT CAN BE ATTRIBUTED TO A REDUCED CHARGE CAPACITY OF THE INTERNAL NIMH BATTERY. CAPA PR00492825 INVESTIGATED INTERNAL BATTERY ISSUES WITH CONTROLLER 2.0. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE OF THE STUCK DRIVELINE COVER/DRIVELINE MAY BE ATTRIBUTED, BUT NOT LIMITED, TO IMPROPER HANDLING OF THE DEVICE. A POSSIBLE ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, POTENTIALLY ASSOCIATED WITH THE REPORTED ATTEMPTED CONTROLLER EXCHANGES, AND/OR A MARGINAL DRIVELINE CONNECTION. BASED ON THE INVESTIGATION CONDUCTED AND THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE REPORTED ELECTRICAL FAULT ALARM, THE SUBSEQUENT VAD STOPPED ALARM, AND THE REPORTED POOR MECHANICAL CONNECTION EVENT CAN BE ATTRIBUTED TO A MARGINAL DRIVELINE CONNECTION AND/OR DAMAGE TO THE DRIVELINE CONNECTOR ASSOCIATED WITH THE CONTROLLER CONNECTOR PIECE GETTING LODGED AROUND THE PINS OF THE DRIVELINE, WHICH MAY BE RELATED TO THE HANDLING OF THE DEVICE WHEN DISCONNECTING THE DRIVELINE CONNECTOR DURING TROUBLESHOOTING OF THE CONTROLLER ALARM. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DRIVELINE SHEATH DAMAGE AND DISCOLORATION MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING DESIGN ISSUES AND/OR EXPOSURE TO UV LIGHT. A POSSIBLE ROOT CAUSE OF THE OBSERVED INNER LUMEN DAMAGE MAY BE ATTRIBUTED TO HANDLING OF THE DEVICE AND/OR WEAR OVER TIME AFTER THE SHEATH DAMAGE LEFT THE INNER LUMEN EXPOSED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE DRIVELINE STRAIN RELIEF DAMAGE MAY BE ATTRIBUTED, BUT NOT LIMITED, TO FACTORS SUCH AS NORMAL WEAR OVER TIME AND/OR IMPROPER HANDLING. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 14-DEC-2022, H3: YES, D4: SERIAL OR LOT#: (B)(6), D9: NO, H3: YES; D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 14-DEC-2022, H3: YES; D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 11-SEP-2023, H3: YES; D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 07-SEP-2023 H3: YES D4: SERIAL OR LOT#: BAT941649 D9: YES, RETURN DATE: 07-SEP-2023 H3: YES; D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 07-SEP-2023 H3: YES, D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 07-SEP-2023, H3: YES D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 07-SEP-2023, H3: YES. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. CORRECTION TO D4: UNIQUE IDENTIFIER (UDI). INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAILED AND AUDIBLE HAZARD ALARMS. THE PATIENT WAS ALERT AND CONSCIOUS, THEN SUDDENLY FELT UNWELL, LAID DOWN AND LOST CONSCIOUSNESS. THE PATIENT BECAME UNRESPONSIVE BUT WAS BREATHING. IT WAS NOTED THAT THE PATIENT¿S SPOUSE ATTEMPTED TO DO A CONTROLLER EXCHANGE, BUT THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE AND THE DRIVELINE COVER WOULD NOT COME OUT OF THE CONTROLLER. AFTER MANY ATTEMPTS THE PATIENT¿S SPOUSE WAS ABLE TO REMOVE THE DRIVELINE AND INSERT IT INTO THE BACK UP CONTROLLER BUT THE DRIVELINE WOULD NOT INSERT INTO THE PORT. THE PATIENT¿S SPOUSE CONTINUED TO ATTEMPT TO INSERT THE DRIVELINE, BUT IT DID NOT MAKE THE CONNECTION DUE TO MEETING RESISTANCE. POLICE DEPARTMENT AND EMERGENCY SERVICES ARRIVED AND ALSO TRIED TO INSERT THE DRIVELINE INTO THE BACK UP CONTROLLER BUT WERE UNSUCCESSFUL. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. ATTEMPTS TO INSERT DRIVELINE BACK INTO PRIMARY CONTROLLER WERE ALSO UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED VIA AMBULANCE AND WAS INTUBATED ON THE WAY. CPR AND RESUSCITATION WERE CONTINUED IN THE EMERGENCY DEPARTMENT (ED). A NEW CONTROLLER PROGRAMED IN THE HOSPITAL W AS BROUGHT TO THE ED AND ATTEMPTS TO CONNECT THE DRIVELINE TO IT WERE ALSO UNSUCCESSFUL AND CONTINUED RESISTANCE WAS MET. MORE ATTEMPTS WERE MADE BY SEVERAL VAD TRAINED STAFF. THE DRIVELINE WAS INSPECTED, AND A PIECE OF METAL APPEARED TO BE LODGED AROUND THE PINS IN THE DRIVELINE. LOG FILE REVIEW REVELED THAT THE CONTROLLER ALSO EXHIBITED AN ELECTRICAL FAULT ALARM. THE PATIENT WAS NOT AN EXTR ACORPOREAL MEMBRANE OXYGENATION (ECMO) CANDIDATE DUE TO HIS AGE AND THE PROLONGED PERIOD OF TIME WITHOUT FLOW. BECAUSE POWER COULD NOT BE RESTORED TO THE VAD AND THE PATIENT HAD PROLONGED CPR, THE DECISION WAS MADE TO END CPR AS CARDIAC SUPPORT COULD NOT BE REESTA BLISHED. THE PATIENT EXPIRED.
IT WAS FURTHER REPORTED THAT LOGFILE REVIEW REVEALED THAT THE CONTROLLER EXHIBITED UNEXPECTED POWER LOSS AND A CONTROLLER FAULT ALARM INDICATING INTERNAL BATTERY END OF LIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419437 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707000017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Death |