MAUDE Adverse Event Report: HEART VALVES SANTA ANA BAND 620BG31 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620BG31
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this annuloplasty band was implanted and explanted on the same day.The device was replaced with a bioprosthetic valve for unknown reasons.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received from the physician indicated that this case was a complex mini-mitral valve repair procedure that the physician felt was inadequate on transesophageal echocardiogram (tee).The failure was a combination of an issue with the native tissue and the physician not being able to identify the source of the problem.The physician did not want to put the patient on a cross-clamp for the third time, so the physician decided to perform a chordal preserving replacement procedure with a bioprosthetic valve.The mini-thoracotomy was closed only once at the end of the procedure.The patient experienced some post-operative atrial fibrillation (afib) and was discharged four days later.At the one month follow-up, the physician reported that the patient is doing well.No other adverse patient effects were reported.Added patient weight.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BAND 620BG31 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6699997
• Report Number: 2025587-2017-01141
• Device Sequence Number: 19324579
• Product Code: KRH
• UDI-Device Identifier: 00613994759122
• UDI-Public: 00613994759122
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: 620BG31
• Device Catalogue Number: 620BG31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 98