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 Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient had stroke following lvad implant on (b)(6)2020 in the left cerebral hemisphere area.Patient presented at that time with aphasia.Additional information states that patient had an ischemic stroke, the anticoagulation was held peri/post operatively.Ct scan was performed.Patient had aphasia post-extubating.Resumption delayed due to concern for hemorrhagic conversion.Anticoagulation resumed without incident on post operative day 4.A serial head ct and neuro exams stable from time of incident to time of resumption.

Event Description

It was later reported that the patient also had a subarachnoid hemorrhage.The patient was immediately post-implant at the time of the initial cerebrovascular accident (cva).The patient had a head computed tomography (ct) scan.The patient was aphasic after extubation following surgical implant.The patient underwent serial ct scans and was treated with conservative anticoagulation.There was no surgical intervention.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6) until they ultimately expired on (b)(6) 2020 (addressed under mfr # 2916596-2020-05264).No product is available for investigation.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 to the customer on (b)(6) 2020.The heartmate 3 lvas ifu lists stroke, bleeding and other neurological events (not stroke-related) as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Additionally, section 6 lists neurologic dysfunction as a potential late postimplant complication that may be associated with the use of heartmate 3 left ventricular assist system.This section also contains information regarding the recommended anticoagulation therapy and inr range.No further information was provided.The manufacturer is closing 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: 10750604
• MDR Text Key: 213657697
• Report Number: 2916596-2020-05273
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7550516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 97