MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982)

Event Date 12/13/2020

Event Type  Death  

Manufacturer Narrative

The patient's complicated hospital course ventilator-dependent respiratory failure, anuric renal failure and septic shock due to bacteremia, right groin hematoma, sacral decubitis ulcers status post diverting loop sigmoid colostomy and gastrostomy-jejunostomy (gj) tube, profound lower extremity weakness likely due to spinal infarct status, hemorrhagic shock post gastrointestinal bleed, ventilator-associated pneumonia post antibiotics, and altered mental status with concern for sepsis.The patient's complicated medical history was reported under mfr report number of the heartmate pump 2916596-2021-00079 and mfr report number of the centrimag pump 3003306248-2021-00007.No further information was provided.A supplemental report will be submitted when the manufacturers investigation is completed.

Event Description

It was reported that the patient was transferred from the floor to the critical care unit (ccu) on (b)(6) 2020 for specifically altered mental status with a blown right pupil initially concerned for central nervous system (cns) bleed.When the patient arrived, the patient's venous blood gas (vbg) was 7.0/67.The patients arms were rigid, unresponsive, and the right pupil was dilated and not reactive.An amp of bicarbonate was pushed, placed on vent 6cc/kg, respiratory rate (rr) was 28, and mean arterial pressure (map) was 72.The patients mental status slowly started to improve.The repeat vbg was 7.13/54, increased rr to 32 and pushed another amp of bicarbonate.The plan was to start continuous renal replacement therapy (crrt) following head imaging for profound metabolic acidosis.The head computed tomography was within normal limits.Per further chart review, the patient had a history of right corneal transplant.As patients mental status improved overnight in ccu, he communicated he did not want any further interventions including dialysis, ventilation, further blood draws or any life prolonging medications that did not directly contribute to comfort.It was confirmed this was consistent with discussions with the nurse.Due to complicated hospital course, the family and patient requested comfort care only.There were multiple discussions with the healthcare professional team and hospice team where the patient and patient's wife confirmed these wishes to transition to comfort care only.The patients icd (implantable cardioverter defibrillator) was turned off and patient was transitioned to comfort care only.The patient expired on (b)(6) 2020.The death was not related to the lvad (left ventricular assist device) and no autopsy was performed.The pump will not be returned for analysis.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not conclusively be established through this evaluation.The heartmate 3 lvas instructions for use (ifu) lists respiratory failure and neurological event (not stroke-related) as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2019.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11178992
• MDR Text Key: 227109117
• Report Number: 2916596-2020-06542
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7305438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 53 YR
• Patient Weight: 101