HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
Report
- Report Number
- 3007042319-2022-05480
- Event Type
- Injury
- Date Received
- June 22, 2022
- Date of Event
- June 9, 2022
- Report Date
- September 16, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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: 31-AUG-2021, 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: 20-AUG-2020, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2021, SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-MAR-2021, 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: 24-MAR-2020, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-MAR-2021, 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: 24-MAR-2020, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-OCT-2021, 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: 28-OCT-2020, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-OCT-2021, 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: 28-OCT-2020, LABELED FOR SINGLE USE: NO, (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE OUTFLOW GRAFT LOT NUMBER, INTERVENTION, PATIENT IMPACT OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE CONCOMITANT VAD THERAPY DATE; D10 WAS UPDATED. 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 IS BEING SUBMITTED FOR CORRECTION. CORRECTED SECTIONS: - B5 DESC EVT PROBLEM: CORRECTED TO MANUFACTURER¿S ANALYSIS THAT REVEALED A LOW FLOW EVENT. - H10 ADDT MANUFACTURER FOR MDR: CORRECTED TO INCLUDE THE VAD DETAILS AND CODE AS AN ADDITIONAL PRODUCT ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PUMP D4: MODEL #: 1104/ CATALOG #: 1104/ EXPIRATION DATE: UNK / SERIAL #: (B)(6) UDI #: ASKU D9: NO H3: YES H4: MFG DATE: UNK H5: YES H6: PATIENT IME CODE(S): E0514 H6: IMF CODE(S): F12 H6: IMG CODE(S): G04105 H6: FDA DEVICE CODE(S): A1412 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D12 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.
A SUPPLEMENTAL IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS: (B)(6)¿ CONTROLLER 2.0 H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01, D02, D15 (B)(6)¿ BATTERY H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01, D02 (B)(6)¿ BATTERY H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01, D02 (B)(6)¿ BATTERY H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01, D02 (B)(6)¿ BATTERY H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 (B)(6)¿ BATTERY H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 PRODUCT EVENT SUMMARY: THE ASSOCIATED OUTFLOW GRAFT OF AN UNKNOWN LOT NUMBER, ONE (1) CONTROLLER ((B)(6)), AND FIVE (5) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. THE LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). LOG FILE ANALYSIS ALSO REVEALED TEN (10) CONTROLLER POWER UP EVENTS WITH ASSOCIATED PUMP START EVENTS LOGGED BETWEEN 28-MAY-2022 AND 13-JUN-2022. SEVERAL MOMENTARY DISCONNECTIONS WERE OBSERVED LEADING UP TO SEVERAL OF THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF ELEVEN (11) SECONDS PER LOSS OF POWER. ANALYSIS OF THE ALARM LOG FILE DID NOT REVEAL ANY POWER DISCONNECT ALARMS WITHIN THE ANALYZED PERIOD. HOWEVER, REVIEW OF THE DATA LOG FILE REVEALED INSTANCES INVOLVING (B)(6), WHERE THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) VALUE WERE LOGGED BETWEEN 101-201, WHICH IS INDICATIVE OF COMMUNICATION ERRORS. A COMMUNICATION ERROR WILL TRIGGER A POWER DISC ONNECT ALARM IF THE OTHER POWER SOURCE IS A BATTERY WITH AN RSOC GREATER THAN 25%. ADDITIONALLY, LOG FILE ANALYSIS REVEALED SEVERAL INTERMITTENT DECREASES IN POWER CONSUMPTION AND ESTIMATED FLOWS WITHIN THE NORMAL OPERATING RANGE WERE OBSERVED BETWEEN 27-MAY-2022 AND 12-JUN-2022; HOWEVER, NO ALARMS WERE LOGGED FOR THE PAST 14 DAYS LEADING UP TO (B)(6) 2022. AS A RESULT, THE REPORTED PREMATURE POWER SWITCHING, LOSSES OF POWER, AND POWER DISCONNECT ALARMS EVENTS WERE CONFIRMED. THE REPORTED OUTFLOW GRAFT OCCLUSION EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. INFORMATION PROVIDED BY THE SITE INDICATED THAT THERE WAS A QUESTIONABLE THROMBUS IN THE OUTFLOW GRAFT. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. (B)(6) WERE LUBRICATED PRIOR TO RELEASE. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE BATTERIES (B)(6). WHILE THE PRODUCTS WERE NOT AVAILABLE FOR PHYSICAL ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION SERVICING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALL WITHIN THE BOUNDS OF THIS CAPA. A POSSIBLE ROOT CAUSE OF THE LOSSES 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. POSSIBLE ROOT CAUSES OF THE OBSERVED COMMUNICATION ERRORS, AND RESULTING POWER DISCONNECT ALARMS, CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERIES, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE OBSERVED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED, AND/OR CONSTRICTION AT THE OUTFLOW GRAFT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF THROMBUS. 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 REPORTED THAT FIVE BATTERIES EXHIBITED MULTIPLE POWER DISCONNECT ALARMS. APPROXIMATELY TWO DAYS LATER, THE CONTROLLER EXHIBITED POWER UP EVENTS ASSOCIATED WITH LOSSES OF POWER. IT WAS FURTHER REPORTED THAT POWER SWITCHING WAS SUSPECTED AND THERE WAS A QUESTIONABLE THROMBUS IN THE OUTFLOW GRAFT. THE CONTROLLER AND OUTFLOW GRAFT REMAIN IN USE AND THE BATTERIES WERE ALL REMOVED FROM SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
MANUFACTURER¿S ANALYSIS REVEALED A LOW FLOW EVENT. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624413 | HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | 1104 VAD |