HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2020-00350
- Event Type
- Injury
- Date Received
- February 3, 2020
- Date of Event
- January 16, 2020
- Report Date
- March 10, 2020
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707003261
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND CORRECTION. CORRECTION: G4 UPDATED TO INCLUDE PMA/510(K) NUMBER P100047. PRODUCT EVENT SUMMARY: THE PUMP WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SUSTAINED DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS BEGINNING ON (B)(6) 2020, FOLLOW BY SUDDEN DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON (B)(6) 2020 TO PARAMETERS BELOW THE NORMAL OPERATING RANGE. SEVERAL LOW FLOW ALARMS HAVE BEEN RECORDED SINCE (B)(6) 2020. OF NOTE, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH HEPARIN INTRAVENOUS (IV) DRIP AND UNDERWENT AN EMBOLECTOMY TO ADDRESS THE LOW FLOWS, WHICH CORRESPONDS WITH THE RETURN TO BASELINE PARAMETERS IN THE LOG FILES. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION AND THE AVAILABLE INFORMATION, 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, POOR VAD FILLING, AND/OR PATIENT RELATED FACTORS. 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. 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.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOW FLOW ALARMS. THE PATIENT ADDITIONALLY HAD LOW BLOOD PRESSURE AND WAS GIVEN A BOLUS OF FLUIDS. LOW FLOWS REMAINED BUT MEAN ARTERIAL PRESSURE INCREASED. LACTATE DEHYDROGENASE (LDH) WAS 595 AND INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.5 WHEN THE PATIENT PRESENTED TO THE EMERGENCY ROOM; HEPARIN INTRAVENOUS (IV) DRIP WAS INITIATED. THE PATIENT ALSO HAD HEMOLYSIS. IT WAS NOTED THAT LDH FOR THE LAST TWO MONTHS HAS BEEN ELEVATED IN THE 450-600 RANGE. AFTER ADMISSION, THE PATIENT'S ECHOCARDIOGRAM SHOWED NO FLOW BUT LARGE LEFT VENTRICULAR AND ATRIOVENTRICULAR OPENING EACH BEAT. IT WAS STATED THAT LOG FILES APPEARED TO BE CONSISTENT WITH OCCLUSION. LOG FILE ANALYSIS REVEALED BELOW NORMAL POWER CONSUMPTION. IT WAS SUSPECTED THAT THE PATIENT HAD AN OCCLUSION OF THE INFLOW CANNULA. THE VENTRICULAR ASSIST DEVICE (VAD) SPEED WAS ADJUSTED WITH SLIGHT IMPROVEMENT IN FLOWS. THE PATIENT WAS GIVEN ADDITIONAL FLUIDS BUT THEN DEVELOPED SUDDEN PAIN IN THE LEFT LEG AND THE SITE WAS UNABLE TO FIND A PULSE IN THE LEFT LEG; THE PATIENT HAD "BOUNDING PULSE IN RIGHT LEG". THE PATIENT UNDERWENT EMERGENT EMBOLECTOMY AND THROMBOSIS WAS REMOVED FROM BIFURCATION OF THE LEFT FEMORAL ARTERY. 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 |
|---|---|---|---|---|---|---|---|
| 122172 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707003261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| L| R |