MAUDE Adverse Event Report: HEART VALVES SANTA ANA RING PROFILE 3D 30MM; RING, ANNULOPLASTY

Model Number 680R30

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Insufficiency (1963); No Consequences Or Impact To Patient (2199)

Event Date 04/12/2013

Event Type  Injury  

Event Description

Medtronic received information that 13 days following the implant of this mitral annuloplasty ring, there was ring dehiscence and moderate mitral insufficiency seen on echocardiogram.The patient had no symptoms.15 days post implant, a re-operation of the profile 3d without explant was performed where three dehiscent sutures were replaced by three sutures and two pledgeted sutures.It was reported that the patient had fibroelastic deficiency.At the time of the implant, it was reported there was valve dilatation, papillary fibrosis, leaflet hypertrophy and chronic atrial fibrillation.No adverse patient effects were reported following the reoperation.

Manufacturer Narrative

Product analysis: the product remains implanted.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.The device history record was reviewed and showed that this product met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.It was reported that the patient had a fibroelastic deficiency and this may have contributed to the clinical observation.(b)(4).

Manufacturer Narrative

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

• Brand Name: RING PROFILE 3D 30MM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3562087
• MDR Text Key: 4059322
• Report Number: 2025587-2014-00004
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 680R30
• Device Catalogue Number: 680R30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• 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: 00057 YR
• Patient Weight: 86