HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Report
- Report Number
- 3007042319-2020-00170
- Event Type
- Death
- Date Received
- January 16, 2020
- Date of Event
- December 25, 2019
- Report Date
- May 18, 2022
- 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
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2019 / SERIAL #: (B)(6), UDI #: (B)(4). D10: YES, RETURN DATE: 15-JAN-2020. H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES. H4: MFG DATE: 10-OCT-2018. H5: NO H6: PATIENT CODE(S): C35053, C50403. H6: DEVICE CODE(S): C63030. H6: FDA RESULTS CODE(S): 3233. H6: FDA CONCLUSION CODE(S): 11. 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 EVALUATION AND A CORRECTION TO INCLUDE FDC 22. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND ONE CONTROLLER (B)(6)) WERE NOT RETURNED FOR EVALUATION. THE OTHER CONTROLLER (B)(6)) AND THE BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. FUNCTIONAL TESTING OF THE CONTROLLER REVEALED THAT THE VOLUME OF ALARMS WAS AUDIBLE; THE NO POWER ALARM WOULD SOUND WHEN BOTH POWER SOURCES WERE DISCONNECTED. AS A RESULT, THE REPORTED VISUAL INSPECTION OF THE RETURNED CONTROLLER REVEALED CONTAMINATION WITHIN THE POWER PORTS OF THE CONTROLLER, LIKELY DUE TO THE HANDLING OF THE DEVICE. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. TH E EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLERS IN USE DURING THE REPORTED EVENT CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES FOR THE RETURNED CONTROLLER REVEALED A PREMATURE POWER SWITCHING EVENT THAT WAS DUE TO A MOMENTARY DISCONNECTION INVOLVING (B)(6) WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. LOG FILE ANALYSIS FOR THE RETURNED CONTROLLER ALSO REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2019, AT 02:27:35. THE DATA POINT LOGGED IN THE CONTROLLER'S INTERNAL LOGS PRIOR TO THE LOSS OF POWER REVEALED THAT A BATTERY WAS CONNECTED TO POWER PORT ONE (1) WITH 24% RELATIVE STATE OF CHARGE (RSOC) AND A BATTERY WAS CONNECTED TO POWER PORT TWO (2) WITH 23% RSOC. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT A DIFFERENT BATTERY WAS CONNECTED TO POWER PORT ONE (1) AND NO POWER SOURCE WAS CONNECTED TO POWER PORT TWO (2). SEVERAL MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR 15 SECONDS. A LOSS OF POWER WILL CAUSE THE CONTROLLER DISPLAY TO GO BLANK AND A LOUD, CONTINUOUS ALARM WILL SOUND. LOG FILE ANALYSIS DID NOT REVEAL ANY CRITICAL BATTERY ALARMS WITHIN THE ANALYZED PERIOD; PRIOR TO THE LOSS OF POWER, ANALYSIS OF THE DATA LOGS REVEALED A LOW BATTERY ALARM WAS RECORDED. REVIEW OF THE CONTROLLER LOG FILES FOR THE OTHER CONTROLLER REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2019 AT 02:48:03. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER LAST HAD POWER ON (B)(6) 2017. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE CONTROLLER POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED AT 02:48:39 ON (B)(6) 2019, INDICATING THAT THE POWER UP EVENT OCCURRED DURING THE REPORTED CONTROLLER EXCHANGE. AS A RESULT, THE REPORTED LOW BATTERY ALARM, LOSSES OF POWER, AND "SCREEN WENT BLANK" EVENTS WERE CONFIRMED. HOWEVER, THE REPORTED "NO HIGH PRIORITY ALARM" COULD NOT BE CONFIRMED. REVIEW OF THE CONTROLLER LOG FILES FOR THE RETURNED CONTROLLER REVEALED ONE LOW FLOW ALARM LOGGED ON (B)(6) 2019 AT 02:32:24. REVIEW OF THE LOG FILES FOR THE OTHER CONTROLLER REVEALED SEVERAL DECREASES IN ESTIMATED FLOW TO PARAMETERS BELOW THE NORMAL OPERATING RANGE SINCE (B)(6) 2019 AND 68 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2019. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED LOW FLOW EVENT. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON FOUR OF THE BATTERIES ON (B)(6) 2018. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON THE FIFTH BATTERY ON (B)(6) 2019. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER AND "SCREEN WENT BLANK" EVENT INVOLVING THE RETURNED CONTROLLER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE POWER SOURCE. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW BATTERY ALARM CAN BE ATTRIBUTED TO BOTH BATTERIES BEING DEPLETED TO BELOW 25% RELATIVE STATE OF CHARGE. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOSS OF POWER INVOLVING THE OTHER CONTROLLER CAN BE ATTRIBUTED TO A CONTROLLER EXCHANGE. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR PATIENT RELATED FACTORS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PR E-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 22, 4307 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 22, 67 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 22, 67 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 22, 67 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213, 174, 331 H6: FDA CONCLUSION CODE(S): 12, 19, 22, 4307, 4315 D4: SERIAL #: CON306706 H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 22, 67 D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 22, 67 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. 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.
THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00595825 DUE TO AN FDA AUDIT OBSERVATION. CORRECTED SECTIONS: - B2 OUTCOME ATTRIBUTED TO ADVERSE EVENT: CORRECTED TO CHECK OFF "DEATH" - B2 DATE OF DEATH: CORRECTED TO INCLUDE DATE "(B)(6) 2020" - B5: DESC EVT PROBLEM: CORRECTED TO INCLUDE ADDITIONAL ADVERSE EVENT EXPERIENCED BY THE PATIENT - H1 TYPE OF REPORTABLE EVENT: CORRECTED TO CHECK OFF "DEATH" - H6 PATIENT CODES (IME/ANNEX E), IMF (ANNEX F) HEALTH IMPACT, DEVICE CODES (FDD/ANNEX A), IMG (ANNEX G) COMPONENT, FDA METHOD CODE, FDA RESULTS CODE, FDA CONCLUSION CODE: CORRECTED TO INCLUDE NEW ANNEX CODES THAT REFLECT THE REPORTED EVENT. - H10 ADDT MANUFACTURER FOR MDR: CORRECTED THE PRODUCT EVENT SUMMARY TO INCLUDE THE REPORTED EVENT FOR ADVERSE EVENT AND MALFUNCTION. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D12, D02 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G04035 H6: FDA DEVICE CODE(S): A160102, A0708 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C04, C06, C15 H6: FDA CONCLUSION CODE(S): D12, D11, D15, D01, D02 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G04035 H6: FDA DEVICE CODE(S): A0708 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL #: (B)(6) H6: PATIENT IME CODE(S): E011903, E2310, E0611 H6: IMF CODE(S): F21, F23, F08, F02 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B01 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 PRODUCT EVENT SUMMARY: VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND ONE (1) CONTROLLER ((B)(6)) WERE NOT RETURNED FOR EVALUATION. ONE (1) CONTROLLER ((B)(6)) AND FIVE (5) BATTERIES ((B)(6)) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER (B)(6) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. FUNCTIONAL TESTING OF THE CONTROLLER REVEALED THAT THE VOLUME OF ALARMS WAS AUDIBLE; THE NO POWER ALARM WOULD SOUND WHEN BOTH POWER SOURCES WERE DISCONNECTED. AS A RESULT, THE REPORTED VISUAL INSPECTION OF CON307024 REVEALED CONTAMINATION WITHIN THE POWER PORTS OF THE CONTROLLER, LIKELY DUE TO THE HANDLING OF THE DEVICE. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLERS IN USE DURING THE REPORTED EVENT ((B)(6)) CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES FOR (B)(6) REVEALED A PREMATURE POWER SWITCHING EVENT THAT WAS DUE TO A MOMENTARY DISCONNECTION INVOLVING (B)(6) WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. LOG FILE ANALYSIS FOR (B)(6) ALSO REVEALED A CONTROLLER POWER UP EVENT ON 25-DEC-2019, AT 02:27:35. THE DATA POINT LOGGED IN THE CONTROLLER'S INTERNAL LOGS PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 24% RELATIVE STATE OF CHARGE (RSOC) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 23% RSOC. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND NO POWER SOURCE WAS CONNECTED TO POWER PORT TWO (2). SEVERAL MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO THE LOSS OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR 15 SECONDS. A LOSS OF POWER WILL CAUSE THE CONTROLLER DISPLAY TO GO BLANK AND A LOUD, CONTINUOUS ALARM WILL SOUND. LOG FILE ANALYSIS DID NOT REVEAL ANY CRITICAL BATTERY ALARMS WITHIN THE ANALYZED PERIOD; PRIOR TO THE LOSS OF POWER, ANALYSIS OF THE DATA LOGS REVEALED A LOW BATTERY ALARM WAS RECORDED. REVIEW OF THE CONTROLLER LOG FILES FOR (B)(6) REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2019 AT 02:48:03. REVIEW OF THE EVENT LOG FILE REVEALED THAT THE CONTROLLER LAST HAD POWER ON (B)(6) 2017. ADDITIONALLY, REVIEW OF THE DATA LOG FILE REVEALED THAT THE CONTROLLER WAS NOT IN USE PRIOR TO THE CONTROLLER POWER UP EVENT; THE FIRST DATA POINT WAS LOGGED AT 02:48:39 ON (B)(6) 2019, INDICATING THAT THE POWER UP EVENT OCCURRED DURING THE REPORTED CONTROLLER EXCHANGE. AS A RESULT, THE REPORTED LOW BATTERY ALARM, LOSSES OF POWER, AND "SCREEN WENT BLANK" EVENTS WERE CONFIRMED. HOWEVER, THE REPORTED "NO HIGH PRIORITY ALARM" COULD NOT BE CONFIRMED. REVIEW OF THE CONTROLLER LOG FILES FOR (B)(6) REVEALED ONE (1) LOW FLOW ALARM LOGGED ON (B)(6) 2019 AT 02:32:24. REVIEW OF THE LOG FILES FOR (B)(6) REVEALED SEVERAL DECREASES IN ESTIMATED FLOW TO PARAMETERS BELOW THE NORMAL OPERATING RANGE SINCE (B)(6) 2019 AND 68 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2019. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON (B)(6)2018. A POWER SOURCE LUBRICATION PROCEDURE WAS PERFORMED ON (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON (B)(6) 2019. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER AND "SCREEN WENT BLANK" EVENT INVOLVING (B)(6) CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE POWER SOURCE. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW BATTERY ALARM CAN BE ATTRIBUTED TO BOTH BATTERIES BEING DEPLETED TO BELOW 25% RELATIVE STATE OF CHARGE. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOSS OF POWER INVOLVING (B)(6) CAN BE ATTRIBUTED TO A CONTROLLER EXCHANGE. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR PATIENT RELATED FACTORS. INFORMATION PROVIDED BY THE SITE INDICATED THAT, FOLLOWING THE LOSS OF POWER EVENT, THAT THE PATIENT WAS ADMITTED FOR RIGHT HEART FAILURE (RHF) FOLLOWING THE SYNCOPAL EVENT. THE PATIENT DID NOT MAKE A FULL RECOVERY AND WAS SENT HOME ON HOSPICE CARE. THE PATIENT SUBSEQUENTLY EXPIRED, AND THE CAUSE OF DEATH WAS THOUGHT TO BE RIGHT VENTRICULAR FAILURE (RVF). BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, INFECTION, RIGHT VENTRICULAR FAILURE, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF SIMILAR ADVERSE EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE IS POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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. 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.
IT WAS FURTHER REPORTED THAT AN ADDITIONAL BATTERY EXHIBITED POWER SWITCHING.
IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED FOR RIGHT HEART FAILURE (RHF) FOLLOWING THE SYNCOPAL EVENT. THE PATIENT DID NOT MAKE A FULL RECOVERY AND WAS SENT HOME ON HOSPICE CARE. THE PATIENT SUBSEQUENTLY EXPIRED, AND THE CAUSE OF DEATH WAS THOUGHT TO BE RIGHT VENTRICULAR FAILURE (RVF).
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: YES, RETURN DATE: 07-JAN-2020. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 26-DEC-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: YES, RETURN DATE: 07-JAN-2020. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 16-DEC-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: YES, RETURN DATE: 07-JAN-2020. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 19-DEC-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-DEC-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: YES, RETURN DATE: 07-JAN-2020. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 19-DEC-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-JUN-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: YES, RETURN DATE: 07-JAN-2020. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEV RTN TO MFR? YES. MFG DATE: 30-JUN-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-JUN-2018 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: NO DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 30-JUN-2017. LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AND LOW FLOWS WHEN THEIR VENTRICULAR ASSIST DEVICE (VAD) STOPPED MOMENTARILY. THE PATIENT RECEIVED A LOW BATTERY ALARM AND AS THEY DISCONNECTED THE BATTERY, THERE WAS A LOSS OF POWER ON THE CONTROLLER AND THE SCREEN WENT BLANK, BUT NO HIGH PRIORITY ALARM TRIGGERED. POWER SWITCHING WAS SUSPECTED ON THE CONTROLLER AND BATTERIES. THE PATIENT WAS DIAPHORETIC AND PALE AND LOW FLOW ALARMS WERE SOUNDING WHEN THE NURSE CHANGED THE CONTROLLER TO THE BACK UP. THE BACKUP CONTROLLER ALSO EXPERIENCED A LOSS OF POWER. IT WAS NOTED THAT THE PATIENT CONTINUED TO HAVE DECREASED FLOW AND PULSATILITY FOLLOWING THE EVENT. THE VAD AND BACKUP CONTROLLER REMAIN IN USE AND THE BATTERIES WERE EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59314 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707000017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Other| D |