MAUDE Adverse Event Report: HEART VALVES SANTA ANA HANCOCK II AORTIC CINCH 21; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505C21

Device Problems Improper Flow or Infusion (2954); Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Aortic Insufficiency (1715)

Event Date 07/12/2018

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 14 years 1 month post implant of this 21 mm aortic bioprosthetic valve, the device was replaced valve-in-valve with a 23 mm transcatheter aortic valve for severe aortic insufficiency.No additional adverse patient effects were reported. .

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC CINCH 21
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 7733089
• MDR Text Key: 115486751
• Report Number: 2025587-2018-01933
• Device Sequence Number: 0
• Product Code: LWR
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2007
• Device Model Number: T505C21
• Device Catalogue Number: T505C21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 01/19/2004
• 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: 89 YR