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

Model Number	10005877
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
Related manufacturer reference number: 2916596-2020-02165.It was reported that during the implant procedure the surgeons had difficulties to connect the pump to the mini apical cuff.The cuff lock of the pump was unable to be locked.The recommended suture technique for the mini apical cuff was used although a bit more tissue was very close to the cuff at lateral, apical quadrant.The surgeon tried to connect the bulky tissue with one single additional suture and afterwards the cuff lock was still not lockable completely.Different positions were tried while connecting the pump onto the cuff.The cuff lock seemed to be canted and they had to use the unlock tool.The locking mechanism was hard to reopen.The surgeon decided to exclude an issue with the cuff lock itself and tested it with the "old" apical cuff.This was successful.The removal of the "test" cuff was not that easy with the unlock tool and afterwards the team noticed that the locking part of the cuff lock was hardly warped and not useable anymore.Due to this issue it was decided to exchange the pump and they added one more corrective suture to the mini apical cuff.The connection of the new pump was uneventful and without any further issues.The implantation went straight forward after and the patient was transferred to the icu under completely stable conditions.The affected pump will be returned for investigation.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the cause of the reported event could not be determined as the mini apical cuff was not returned for evaluation.The account reported that during the implant procedure on (b)(6) 2020, the surgeons had difficulties connecting the pump to the mini apical cuff.The cuff lock of the pump was not lockable.The company¿s recommended suture technique for the mini apical cuff was used.It was reported that a bit more tissue was very close to the cuff at the lateral, apical quadrant.The surgeon tried to correct the bulky tissue with one single additional suture.Afterwards, the cuff lock was still not able to be locked completely.Despite several attempts, the surgeon was not able to connect the pump to the mini apical cuff.Additionally, it was reported that the locking mechanism was difficult to reopen after testing the pump with a ¿test¿ apical cuff.Due to this issue, the team decided to exchange the pump and added one more corrective suture to the mini apical cuff.The connection to the new pump was uneventful and no further issues were noted.The implant procedure was straightforward following the pump exchange.The patient was then transferred to the intensive care unit (icu) under completely stable conditions.It was reported that the affected pump would be returned for investigation.Review of the manufacturing documentation for the mini apical cuff found no deviations from manufacturing or quality assurance specifications.The cause of the cuff lock engagement issue could not be determined.There was no harm to the patient, who was reported to be stable and without complications following surgery.The patient remains ongoing on support from the heartmate 3 lvas with no further issues reported.The surgical procedures section of the heartmate 3 lvas ifu provides guidance on how to insert the pump into the ventricle and includes steps to ensure proper engagement of the cuff lock.This section also warns that, during the implant process, a complete backup system must be available on-site and in close proximity for use in an emergency.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9992471
• Report Number: 2916596-2020-02253
• Device Sequence Number: 2093083
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 7306316
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEARTMATE 3 LVAS, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention