HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-02297
- Event Type
- Death
- Date Received
- February 6, 2022
- Date of Event
- January 1, 2021
- Report Date
- February 6, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
EVENT SUMMARY: A PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED AN INFECTION, RESPIRATORY FAILURE REQUIRING INTUBATION, AND SUSTAINED SUPRAVENTRICULAR ARRHYTHMIA REQUIRING INTERVENTION. THE PATIENT WAS WITHDRAWN FROM SUPPORT AND SUBSEQUENTLY EXPIRED. REVIEW OF THE STERILITY CERTIFICATE COULD NOT BE PERFORMED SINCE THE PUMP SERIAL NUMBER IS UNKNOWN. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, INFECTION, RESPIRATORY DYSFUNCTION AND CARDIAC ARRHYTHMIA ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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. THIS EVENT WAS REPORTED IN THE Q3 2021 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
EVENT SUMMARY: A PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED AN INFECTION, RESPIRATORY FAILURE REQUIRING INTUBATION, AND SUSTAINED SUPRAVENTRICULAR ARRHYTHMIA REQUIRING INTERVENTION. THE PATIENT WAS WITHDRAWN FROM SUPPORT AND SUBSEQUENTLY EXPIRED. REVIEW OF THE STERILITY CERTIFICATE COULD NOT BE PERFORMED SINCE THE PUMP SERIAL NUMBER IS UNKNOWN. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, INFECTION, RESPIRATORY DYSFUNCTION AND CARDIAC ARRHYTHMIA ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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. THIS EVENT WAS REPORTED IN THE Q3 2021 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, RESPIRATORY FAILURE REQUIRING INTUBATION, AND SUSTAINED SUPRAVENTRICULAR ARRHYTHMIA REQUIRING INTERVENTION. THE PATIENT WAS WITHDRAWN FROM VENTRICULAR ASSIST DEVICE (VAD) SUPPORT AND SUBSEQUENTLY EXPIRED. THE VAD REMAINS IN THE PATIENT. NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. THIS EVENT WAS REPORTED IN THE Q3 2021 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, RESPIRATORY FAILURE REQUIRING INTUBATION, AND SUSTAINED SUPRAVENTRICULAR ARRHYTHMIA REQUIRING INTERVENTION. THE PATIENT WAS WITHDRAWN FROM VENTRICULAR ASSIST DEVICE (VAD) SUPPORT AND SUBSEQUENTLY EXPIRED. THE VAD REMAINS IN THE PATIENT. NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. THIS EVENT WAS REPORTED IN THE Q3 2021 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575227 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Death |