MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 2; VENTRICULAR (ASSISST) BYPASS

Model Number 105306

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2020

Event Type  malfunction  

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 the patient had a low speed event in (b)(6) 2020 (mfr 2916596-2020-03255) with a suspected driveline fracture.The patient had a low speed operation again on (b)(6) 2020 with confirmed reproducibility.X-rays were not taken because the location of the damage cannot often be identified on x-rays.It was decided that the patient remain on battery for the remainder of lvad (left ventricular assistive device) therapy.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: although the reported low speed events were confirmed based on the submitted system controller log files, the cause could not be conclusively determined without a device evaluation.The log file captured multiple low speed events while the system was operating on a power module.The events showed corresponding elevations in pump power and pi.Based on previous experienced, the captured events appear consistent with a potential driveline wire issue.It was reported that the patient remains ongoing on vad support and has switched to only using external batteries while awaiting transplant.No further related issues have been reported.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 2
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10538128
• MDR Text Key: 207187220
• Report Number: 2916596-2020-04397
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: 105306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1