MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 36MM; RING, ANNULOPLASTY

Model Number 680R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that this annuloplasty ring was implanted and explanted during the same procedure as the physician was unhappy with the way the attempted repair looked.The device was replaced with a bioprosthetic valve.No other adverse patient effects were reported.

• Brand Name: RING PROFILE 3D 36MM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES 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: 6935901
• MDR Text Key: 89105191
• Report Number: 2025587-2017-01798
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759207
• UDI-Public: 00613994759207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073324
• 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: 09/18/2017

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: 01/10/2022
• Device Model Number: 680R
• Device Catalogue Number: 680R36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/10/2017
• Date Device Manufactured: 01/11/2017
• 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: 67 YR
• Patient Weight: 78