MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM; RING, ANNULOPLASTY

Model Number 690R

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that immediately following implant of this annuloplasty ring, it was explanted and replaced due to a bend at the anterior limb of the ring digging into the torus-aorticus.The health care professional believed there was chance that with repeated contraction, it could have perforated the right atrium or aorta.No adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM
• 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: 5831541
• MDR Text Key: 50712556
• Report Number: 2025587-2016-01158
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2020
• Device Model Number: 690R
• Device Catalogue Number: 690R28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2015
• 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: 72 YR