MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF, INT; VENTRICULAR (ASSISST) BYPASS

Model Number 105581INT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the sterility of the outflow graft was compromised when it was passed while in its outer packaging from a scout nurse to a scrub nurse.The outflow graft and packaging were removed from the sterile field and the scrub nurse exchanged gloves.A replacement outflow graft was sourced from another implant kit.The contaminated outflow graft was retained by the hospital.After the procedure, the patient was noted to have weakness in their right side.A computerized tomography (ct) scan confirmed a cerebral thrombus that became an embolic stroke.The site believed the patient's aspirin and warfarin medications could have contributed to the event.An embolectomy was performed in the left terminal that revealed an occlusion in the cerebral artery and middle cerebral artery.The patient was transferred to a rehabilitation center for ongoing care.Related mfr#:2916596-2022-01413.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event could not be conclusively determined through this investigation as no images were provided by the account and no product was returned for evaluation.Heartmate 3 sealed outflow graft, lot number 7690512, will not be returned for evaluation as it was retained by the hospital.There was no reported delay to the implant procedure and the patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The device history records for the heartmate 3 outflow graft assembly, lot number 7690512 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) (rev.G) is currently available.Section 5, "surgical procedures" (under ¿unpacking¿), notes to use care when unpacking items, as several must be placed in the sterile fields.This section also provides instructions on how to unpack all of the implant kit components in the operating room, including the pump and accessories tray.The user is also instructed to remove all the sterile components from the accessories tray and place in the sterile work area.In addition, section 5 (under ¿surgical considerations¿) warns that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2022-01413.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF, INT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13730645
• MDR Text Key: 287673318
• Report Number: 2916596-2022-01414
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: 105581INT
• Device Lot Number: 7690512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 86 KG