HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2024-04241
- Event Type
- Injury
- Date Received
- August 1, 2024
- Date of Event
- July 29, 2024
- Report Date
- October 3, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ANALYSIS AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: (B)(6) AND THE ASSOCIATED OUTFLOW GRAFT (LOT 17058548-0604) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. LOG FILE ANALYSIS REVEALED A SLIGHT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2024, FOLLOWED BY A SUDDEN INCREASE IN PARAMETERS ON (B)(6) 2024. 170 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2024. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. OF NOTE, IT WAS REPORTED THAT MULTIPLE STENTS WERE PLACED IN THE OUTFLOW GRAFT ON (B)(6) 2024, WHICH CORRESPONDS WITH OBSERVED INCREASE IN POWER AND FLOW. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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, AND/OR POOR VAD FILLING. PER THE INSTRUCTIONS FOR USE, RENAL DYSFUNCTION AND THROMBUS ARE KNOWN POTENTIAL COMPLICATIONS 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 OUTFLOW GRAFT STENOSIS. 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 ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: OUTFLOW GRAFT SERIAL OR LOT#: (B)(6) H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED 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 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 ¿ OUTFLOW GRAFT D4: MODEL #: 1125 / CATALOG #: 1125 / EXPIRATION DATE: 31-OCT-2022 / SERIAL OR LOT#: (B)(6). 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.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 A STENT WAS PLACED IN THE OUTFLOW GRAFT WITH LITTLE IMPROVEMENT TO FLOWS, SO AN ADDITIONAL STENT WAS PLACED. THE PATIENT CONTINUED HAVING OCCASIONAL LOW FLOWS WHICH WERE ATTRIBUTED TO ACUTE KIDNEY INJURY AND HYPOVOLEMIA. IT WAS NOTED THAT THE PATIENT'S MEAN ARTERIAL PRESSURES WERE MOSTLY BETWEEN 64 AND 80, AND THE PATIENT'S WEIGHT WAS STABLE. THE PATIENT WAS GIVEN A BOLUS OF FLUIDS ON TWO SUBSEQUENT DAYS.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS SEEN IN CLINIC AND WHILE THERE IS WAS NOTED THAT DURING A REVIEW OF LOG FILE DATA THERE WERE MULTIPLE LOW FLOW ALARMS. THE PATIENT WAS ASYMPTOMATIC BUT ADMITTED TO HOSPITAL FOR FURTHER WORKUP. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2249242 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Hospitalization |