HEARTMATE II LVAS
Report
- Report Number
- 2916596-2017-00804
- Event Type
- Death
- Date Received
- April 21, 2017
- Date of Event
- March 16, 2017
- Report Date
- May 25, 2017
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL INFORMATION. THE PREVIOUS HOSPITALIZATIONS MENTIONED WERE REPORTED IN THE INITIAL MEDWATCH REPORT. (B)(4). THE PUMP WAS RETURNED FOR EVALUATION. UPON DISASSEMBLY OF THE PUMP, EXAMINATION OF THE DISTAL-SIDE OF THE INLET STATOR REVEALED A THROMBUS FORMATION SURROUNDING THE INLET BEARING CUP. AN ADDITIONAL LARGER THROMBUS FORMATION WAS FOUND SURROUNDING THE INLET BEARING BALL, OBSTRUCTING APPROXIMATELY 40-50 PERCENT OF THE BLOOD FLOW PATH. THE TWO THROMBI APPEARED SIMILAR IN COLOR AND STRUCTURE NEAR THE INTERFACE AT WHICH THE INLET BEARING CUP AND BALL MEET, SUGGESTING THAT THEY LIKELY DEVELOPED AS ONE FORMATION AND BROKE APART DURING THE DISASSEMBLY PROCESS. BOTH THROMBUS RINGS REVEALED AREAS OF DENATURATION AND ALSO APPEARED TO HAVE FORMED IN LAMINATED LAYERS, INDICATING THAT THE THROMBI DEVELOPED ON THE INLET BEARING CUP AND BALL OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS SUPPORTING THE PATIENT. IN ADDITION, RED TISSUE-LIKE DEPOSITIONS WERE FOUND ON THE BLADES OF THE PROXIMAL-SIDE OF THE ROTOR BODY AS WELL AS IN THE PROXIMAL-SIDE OF THE OUTLET STATOR SITUATED ADJACENT TO THE OUTLET BEARING BALL AND IN CONTACT WITH TWO STATOR BLADES. THE NON-LAMINATED STRUCTURE OF THE DEPOSITIONS SUGGESTS THAT THEY DID NOT INITIALLY DEVELOP IN THE LOCATIONS IN WHICH THEY WERE FOUND. ALTHOUGH THEIR ORIGINS COULD NOT BE CONCLUSIVELY DETERMINED, THE DEPOSITIONS SHOWED A SIMILAR COLOR AND TEXTURE TO PORTIONS OF THE INLET BEARING THROMBI, SUGGESTING THAT THEY MAY HAVE POTENTIALLY BROKEN OFF FROM THE LARGER THROMBUS FORMATIONS FOUND IN THAT LOCATION. THE EVALUATION COULD NOT DETERMINE A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE OBSERVED DEPOSITIONS, OR A DURATION OF TIME FOR WHICH THEY WERE PRESENT IN THE DEVICE; HOWEVER, THEIR PARTIAL OBSTRUCTION OF THE BLOOD FLOW PATH COULD HAVE CONTRIBUTED TO THE REPORTED ELEVATED LDH LEVELS AND HEMATURIA. THE THROMBI COULD HAVE ALSO CREATED INCREASED DRAG ON THE SPINNING ROTOR, CONTRIBUTING TO THE REPORTED INCREASE IN PUMP POWER VALUES CONFIRMED THROUGH THE DATA RECORDED IN THE SUBMITTED SYSTEM CONTROLLER LOG FILES. VISUAL EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. THE EVALUATION OF THE PUMP CONFIRMED THE PRESENCE OF THROMBUS, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED ELEVATED LDH, HEMATURIA, AND ELEVATED PUMP POWER VALUES. HOWEVER, A DIRECT CORRELATION BETWEEN THE EVALUATION FINDINGS OF THE PUMP AND THE REPORTED SIGNS AND SYMPTOMS OF LIVER CONGESTION AS WELL AS RIGHT HEART FAILURE, RENAL FAILURE, AND SUBSEQUENT PATIENT EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
THE REFERENCE TO THE DRIVELINE INFECTION WAS REPORTED UNDER MEDWATCH MFR. REPORT #2916596-2017-00803. DEVICE UNIQUE IDENTIFIER (UDI) - DEVICE WAS MANUFACTURED PRIOR TO UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 2 MONTHS. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
ADDITIONAL INFORMATION: EVENT DETAILS: THE PATIENT WAS PREVIOUSLY HOSPITALIZED FOR SUSPECTED PUMP THROMBUS, AND THE LACTATE DEHYDROGENASE (LDH) LEVEL HAD BEEN OVER 900 U/L, WITH AN INCREASE IN PUMP POWER. THE PATIENT WAS NOT A CANDIDATE FOR A PUMP EXCHANGE, AND THE LDH AND INR LEVELS WERE CAREFULLY MONITORED. THE PATIENT¿S LDH LEVEL DURING THIS HOSPITALIZATION WERE IN THE 600'S U/L. IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FLUID OVERLOAD. IV DIURETICS AND INOTROPES WERE INITIATED; HOWEVER, THE FLUID RETENTION INCREASED, OXYGEN NEEDS INCREASED, AND THE PATIENT EXPERIENCED RENAL FAILURE. IT WAS REPORTED THAT RIGHT SIDED HEART FAILURE WAS SUSPECTED. END OF LIFE CARE WAS STARTED, THE LVAD WAS TURNED OFF, AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED ON (B)(6) 2017, THAT THE PATIENT WAS IN THE HOSPITAL FOR FEVER AND WEAKNESS AND A DRIVELINE INFECTION THAT WAS BEING TREATED WITH IV ANTIBIOTICS. THE PATIENT HAD DISPLAYED SOME SIGNS AND SYMPTOMS OF LIVER CONGESTION WITH ELEVATED LIVER ENZYMES. THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) WAS ALSO ELEVATED ON ADMISSION AT 1400 U/L. THE LFT¿S AND LDH TRENDED DOWN WITH HEPARIN, MEDICATION ADJUSTMENTS, AND DIURESIS. IT WAS REPORTED THAT PUMP THROMBOSIS WAS SUSPECTED. IT WAS REPORTED THAT THE PUMP WAS ¿WORKING WELL¿, AND THE PATIENT WAS NOT REQUIRING ANY INOTROPES. THE PATIENT STARTED REQUIRING OXYGEN CONTINUOUSLY APPROXIMATELY 3 WEEKS PRIOR. THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD BEEN ADMITTED BACK TO HOSPITAL FOR POTENTIAL PUMP THROMBUS. THE LDH WAS 950 U/L, AND THE PATIENT EXPERIENCED HEMATURIA. THE PATIENT WAS ON IV HEPARIN AND IV INTEGRILIN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292250 | HEARTMATE II LVAS | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORPORATION | 106015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death| H| R |