MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION POSTERIOR ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number H607M

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); No Information (3190)

Event Date 12/22/2017

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 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The reason for the explant was not reported. no additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve due to stenosis.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: POSTERIOR ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7282214
• MDR Text Key: 100420896
• Report Number: 2025587-2018-00417
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994759177
• UDI-Public: 00613994759177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960356
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: H607M
• Device Catalogue Number: H607M63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Date Device Manufactured: 10/23/2014
• 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: 51 YR