MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION VALVE HANCOCK II AORTIC CINCH 25; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505C

Device Problem Occlusion Within Device (1423)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 12 years and 8 months post implant of this bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to stenosis of the bioprosthetic valve.No additional adverse patient effects were reported.

• Brand Name: VALVE HANCOCK II AORTIC CINCH 25
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7071262
• MDR Text Key: 93348239
• Report Number: 2025587-2017-02303
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• 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: 11/30/2017

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: Health Professional
• Device Expiration Date: 10/12/2007
• Device Model Number: T505C
• Device Catalogue Number: T505C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/30/2017
• Date Device Manufactured: 10/12/2004
• 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: 69 YR