MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC VALVE GRAFT; HEART-VALVE, MECHANICAL

Model Number 502

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Vascular Dissection (3160)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the emergent implant of this 27 mm aortic bioprosthetic valved conduit due to a dissection, the surgeon determined the conduit was too big for the patient, it was explanted and replaced with a 25 mm conduit of the same model.No additional adverse patient effects were reported.

• Brand Name: AORTIC VALVE GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7001351
• MDR Text Key: 91050164
• Report Number: 3008592544-2017-00060
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00643169333697
• UDI-Public: 00643169333697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Model Number: 502
• Device Catalogue Number: 502AG27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Date Device Manufactured: 10/03/2016
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 90