HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
Report
- Report Number
- 3007042319-2025-02509
- Event Type
- Injury
- Date Received
- December 9, 2025
- Date of Event
- December 6, 2025
- Report Date
- April 10, 2026
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707006347
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- 003
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT AND SECTIONS HAVE BEEN UPDATED. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. ADDITIONAL PRODUCTS: SERIAL# (B)(6) H3: YES LOT# 0010336 H3: YES MODEL:1175 H3: YES H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: THE DRIVELINE CABLE ASSOCIATED WITH (B)(6), THE ASSOCIATED DRIVELINE BOOT COVER (UNKNOWN LOT NUMBER), ONE (1) CONTROLLER ((B)(6)), AND ONE (1) SHOULDER PACK (0010336) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE PUMP MET ALL REQUIREMENTS FOR RELEASE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DRIVELINE BOOT COVER, CONTROLLER, AND SHOULDER PACK WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE AND THE DRIVELINE BOOT COVER LOT NUMBER IS UNKNOWN. ON-SITE INSPECTION OF THE DRIVELINE AND VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED EVIDENCE OF A SELF REPAIR, FOREIGN MATERIAL COVERING THE DRIVELINE, INNER LUMEN DAMAGE, AND DAMAGE TO THE INSULATION OF THE GREEN WIRE. IN ADDITION, ON-SITE INSPECTION OF THE DRIVELINE BOOT COVER REVEALED THAT THE DEVICE WAS DEGRADING, HARD, BUT STILL ABLE TO MOVE. A DRIVELINE SPLICE REPAIR AND DRIVELINE COVER REMOVAL WERE PERFORMED TO MITIGATE THE REPORTED CONDITIONS. VISUAL EVIDENCE PROVIDED BY THE SITE ADDITIONALLY REVEALED CONTAMINATION ON THE CONTROLLER HOUSING NEAR THE CONTROLLER'S LIQUID CRYSTAL DISPLAY (LCD) AS WELL AS DAMAGE TO THE SHOULDER PACK PLASTIC VIEWING WINDOW AND CONTAMINATION OF THE SHOULDER PACK. THE MOST LIKELY ROOT CAUSE OF THE REPORTED SHOULDER PACK AND CONTROLLER CONTAMINATION EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND THE HANDLING OF THE PACK, AS DESCRIBED IN THE EVENT DETAILS. CAPA PR00519581 WAS CREATED TO INVESTIGATE DAMAGED PACKS. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TEN (10) HIGH WATT ALARMS LOGGED SINCE (B)(6) 2025 AND SEVENTY-SEVEN (77) REACTIVATION EVENTS LOGGED BETWEEN (B)(6) 2025 AND (B)(6) 2025, TEN (10) ELECTRICAL FAULT ALARMS LOGGED BETWEEN (B)(6) 2025 AT 18:22:06 AND (B)(6) 2025 AT 23:09:04, INDICATING AN OVERCURRENT TRIP ON THE REAR STATOR RESULTING IN THE PUMP RUNNING IN SINGLE STATOR OPERATION (FRONT STATOR ONLY). THIS LIKELY TRIGGERED THE OBSERVED HIGH WATT ALARMS DUE TO THE INCREASED POWER CONSUMPTION REQUIRED TO RUN ON A SINGLE STATOR. IN ADDITION, SIX (6) LOW FLOW ALARMS HAVE BEEN LOGGED SINCE (B)(6) 2025. LOG FILE ANALYSIS ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER UP EVENTS ON (B)(6) 2025 AT 10:32:00 AND 11:08:44 AND ONE (1) ASSOCIATED MOTOR START EVENT AT 11:09:05. REVIEW OF THE EVENT LOG FILE REVEALED THAT, PRIOR TO THE POWER-UP EVENT, THE CONTROLLER LAST HAD POWER ON (B)(6) 2025, INDICATING THAT THE CONTROLLER POWER-UP EVENT OCCURRED DURING A CONTROLLER EXCHANGE. REVIEW OF THE ALARM FILE REVEALED ONE (1) VAD DISCONNECT ALARM LOGGED ON (B)(6) 2025 AT 11:08:52, INDICATING THAT THE CONTROLLER WAS POWERED UP WITHOUT THE DRIVELINE CONNECTED. FOLLOWING THE CONTROLLER POWER UP EVENTS, THREE (3) HIGH WATT ALARMS AND THREE (3) REACTIVATION EVENTS AND TWO (2) ELECTRICAL FAULT ALARMS WERE LOGGED, INDICATING AN OPEN PHASE ON THE FRONT STATOR RESULTING IN THE PUMP RUNNING IN SINGLE STATOR OPERATION (REAR STATOR ONLY). THIS LIKELY TRIGGERED THE OBSERVED HIGH WATT ALARMS DUE TO THE INCREASED POWER CONSUMPTION REQUIRED TO RUN ON A SINGLE STATOR. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE LOW FLOW EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOW ALARMS 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 INAPPROPRIATE PUMP ROTATIONAL SPEED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED FOREIGN MATERIAL ON THE CONTROLLER, SHOULDER PACK AND DRIVELINE CABLE CAN BE ATTRIBUTED TO THE IMPROPER HANDLING OF THE DEVICE, AS DESCRIBED IN THE EVENT DETAILS. THE REPORTED DAMAGE TO THE SHOULDER PACK VIEWING WINDOW CAN BE ATTRIBUTED TO WEAR AND THE HANDLING OF THE DEVICE. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, A POSSIBLE ROOT CAUSE OF THE REPORTED HARDENED DRIVELINE COVER EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO LEACHING OF THE PLASTICIZER FROM THE MATERIAL AND/OR DEGRADATION OF THE MATERIAL, RESULTING IN HARDENING. CAPA PR00536773 IS FURTHER INVESTIGATING THIS ISSUE. A POSSIBLE ROOT CAUSE OF THE INNER LUMEN DAMAGE AND DAMAGE TO THE INSULATION OF THE GREEN WIRE MAY BE ATTRIBUTED TO THE HANDLING OF THE DEVICE AND/OR WEAR OVER TIME AFTER THE SHEATH DAMAGE LEFT THE INNER LUMEN EXPOSED. THE MOST LIKELY ROOT CAUSE OF THE SELF-REPAIR EVENT CAN BE ATTRIBUTED TO THE IMPROPER HANDLING OF THE DEVICE. THE MOST LIKELY ROOT CAUSE OF THE ELECTRICAL FAULT ALARMS, HIGH WATT ALARMS, AND OVERCURRENT CONDITION LOGGED ON (B)(6) CAN BE ATTRIBUTED TO THE DAMAGE TO THE DRIVELINE CABLE WIRES; SEVERAL WIRES MAY HAVE COME IN CONTACT WITH EACH OTHER, WHICH WOULD TRIGGER ELECTRICAL FAULTS DUE TO A SHORT CIRCUIT. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE OF THE ELECTRICAL FAULT ALARM DUE TO OPEN PHASE IN THE FRONT STATOR AND SUBSEQUENT HIGH WATT ALARM LOGGED ON (B)(6) MAY BE ATTRIBUTED, BUT NOT LIMITED, TO CONTAMINATION BY FOREIGN MATERIAL OF THE DRIVELINE CONNECTOR OR A MARGINAL CONNECTION BETWEEN THE DRIVELINE AND THE CONTROLLER. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION AND A CORRECTION TO G3. INITIAL REPORT AWARE DATE = 06-DEC-2025. ADDITIONAL PRODUCTS: SHOULDER PACK D4: MODEL #: 2060 / CATALOG #: 2060 / EXPIRATION DATE: 31-DEC-2025 / LOT#: 0010336 H4: MFG DATE: 04-DEC-2024 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.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER 2.0 D4: MODEL # 1420 / CATALOG #:1420 / EXPIRATION DATE: 31-AUG-2021 / SERIAL OR LOT#: (B)(6) D9: NO H3: NO H4: MFG DATE: 20-AUG-2020 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM SHOULDER PACK D4: MODEL #: / CATALOG #: / EXPIRATION DATE: / SERIAL OR LOT#: D9: NO H3: NO H4: MFG DATE:H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM - UNKNOWN DRIVELINE COVER D4: MODEL#: 1175 / CATALOG #: 1175 / EXPIRATION DATE: / LOT#: D9: NO, H3: NO, H4: MFG DATE: H5: NO, H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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 FURTHER REPORTED THAT DRIVE LINE COVER WAS DEGRADING, HARD, BUT STILL ABLE TO SLIDE. THE DL COVER WAS DISCARDED.
IT WAS FURTHER REPORTED THAT THERE WAS INSULATION STRIPPING ON THE INTERNAL WIRES OF THE DRIVELINE AND THE DAMAGE WAS NOT LIMITED TO THE OUTER SHEATH. A SPLICE REPAIR WAS PERFORMED. ALONG WITH THE PROCEDURE, THE CONTROLLER WAS EXCHANGED. REVIEW OF LOG FILES REVEALED THAT THE VAD EXHIBITED ABOVE NORMAL POWER CONSUMPTION AND LOW FLOW ALARMS.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED AN ELECTRICAL FAULT ALARM. THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE CABLE EXHIBITED DAMAGE AND THE PATIENT GLUED THE DRIVELINE CABLE WITH SUPERGLUE, SECURED IT WITH A BLUE SHEET AND ROPE, AND CONCEALED THE PROBLEM WITH A SELF-MADE CABLE COVER WITHOUT INFORMING ANYONE. THE PATIENT ALSO ATTEMPTED TO REPAIR THE TRANSPARENT PLASTIC ON THE SHOULDER PACK WITH SUPERGLUE AND GLUED THE CONTROL UNIT TO THE BAG. THE VAD, CONTROLLER AND SHOULDER PACK REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND MEDICALLY PREPPED FOR THE SPLICE REPAIR. IT WAS ALSO REPORTED THAT THE DRIVELINE COVER WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2796623 | HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1104 | 00888707006347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Hospitalization |