HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-07129
- Event Type
- Injury
- Date Received
- August 30, 2022
- Date of Event
- August 23, 2022
- Report Date
- November 3, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707002639
- 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
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT, MODEL #:1125/ CATALOG #: 1125 / EXPIRATION DATE: 31-AUG-2022 / LOT #: 1420026, UDI #: ASKU, DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 31-AUG-2022, LABELED FOR SINGLE USE: NO. (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT DETAILS 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. 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 AN UPDATE TO: -B5. DESC EVT PROBLEM 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 ADDITIONAL INFORMATION. ADDITIONAL PRODUCTS: 1420026¿ OUTFLOW GRAFT H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D12 PRODUCT EVENT SUMMARY: VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND THE ASSOCIATED OUTFLOW GRAFT (LOT NO. 1420026) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE AVAILABLE CONTROLLER LOG FILES REVEALED A TRANSIENT DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON 23-AUG-2022, FOLLOWED BY A SUSTAINED DECREASE BEGINNING ON 23-AUG-2022 LEADING TO PARAMETERS BELOW NORMAL OPERATING RANGE AND A SUBSEQUENT INCREASE IN POWER AND FLOW ON 24-AUG-2022. FURTHER REVIEW VIA THE AVAILABLE AUTOLOGS REPORTS REVEALED AN ADDITIONAL SUDDEN DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON 25-AUG-2022, FOLLOWED BY A SUDDEN INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ACCOMPANIED WITH IN PUMP ROTATIONAL SPEED ON 25-AUG-2022. REVIEW OF THE AVAILABLE AUTOLOGS REPORT REVEALED 241 LOW FLOW ALARMS HAVE BEEN LOGGED SINCE 23-AUG-2022 AND (3) HIGH WATT ALARMS HAVE BEEN LOGGED SINCE 27-AUG-2022. OF NOTE, THE ALARM THRESHOLD IS WITHIN THE NORMAL OPERATING RANGE AFTER THE INCREASE IN PUMP ROTATIONAL SPEED ON 25-AUG-2022. AS A RESULT, THE REPORTED LOW FLOW, LOW POWER, AND HIGH-POWER EVENTS WERE CONFIRMED. THE REPORTED OCCLUSION EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. INFORMATION PROVIDED BY THE SITE INDICATED THAT VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED AN ABRUPT DECREASE IN FLOWS, POWER AND PULSATILITY DUE TO SUSPECTED INFLOW OR OUTFLOW OBSTRUCTION. OF NOTE, IT WAS REPORTED BY THE SITE THAT THE PATIENT UNDERWENT AN OUTFLOW GRAFT (OFG) REVISION WHERE THE GORE-TEX GRAFT WAS OPENED UP FULLY AND THE PUMP SPEED WAS INCREASED, WHICH CORRESPONDS WITH THE INCREASE IN POWER AND FLOW OBSERVED IN THE LOGS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW AND LOW POWER EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION AT THE OUTFLOW GRAFT DUE TO EXTERNAL COMPRESSION FROM THE ADDITIONAL SURROUNDING GRAFT PLACED BY THE SURGEON AT IMPLANT. BASED ON THE RISK DOCUMENTATION AND THE AVAILABLE, POSSIBLE CAUSES OF THE REPORTED HIGH WATT ALARMS EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING, BUT NOT LIMITED TO AN INAPPROPRIATE PUMP ROTATIONAL SPEED AND/OR INCORRECT SETTING OF THE ALARM THRESHOLD. 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 MEDICAT IONS 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 THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED CONTINUOUS LOW FLOWS ALARMS. THERE HAD BEEN AN ABRUPT DECREASE IN FLOWS, POWER AND PULSATILITY. A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND AN ECHOCARDIOGRAM ARE PENDING TO EVALUATE FOR POSSIBLE INFLOW OR OUTFLOW OBSTRUCTION. THE PATIENT LABS ARE PENDING AND THE PATIENT HAD A LACTATE DEHYDROGENASE (LDH) OF 400, WHICH INCREASED FROM 246 WHILE THE PATIENT WAS AT ANOTHER FACILITY. THE PATIENT'S VITAL SIGNS WERE STABLE AND PATIENT HAD PULSATILE BLOOD PRESSURE AND THE PATIENT DID NOT PRESENT WITH ANY OTHER SYMPTOMS OTHER THAN LOW FLOWS. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT AN OUTFLOW GRAFT (OFG) REVISION AND LOGFILES WERE SUBMITTED FOR HIGH WATTS ALARMS DUE TO SPEED INCREASE THAT HAD OCCURRED AFTER THE OFG REVISION. THE HIGH WATT ALARM LIMIT HAD NOT BEEN ADJUSTED, THEREFORE TRIGGERED THE ALARM. THE PATIENT LDH WAS NOW 220 (189), AND THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC AND THE PATIENT WAS DOING WELL. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT AN OFG REVISION/OPENED UP WAS PERFORMED TO SEE IF THERE WERE GORTEX AROUND THE OFG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144124 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707002639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Hospitalization| R | 6935M62 LEAD, DVFB1D4 ICD |