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

Model Number H607M63

Device Problem Malposition of Device (2616)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Rupture (2208)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Citation: mori m.Rupture of gore-tex neochordae 10 years after mitral valve repair.J thorac dis.2017 apr;9(4):e343-e345.Doi: 10.21037/jtd.2017.03.64.Earliest date of publish used for event date in b3.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.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 Description

Medtronic received information via literature of a (b)(6) year-old male patient with severe mitral regurgitation ten years after the implant of a 63mm medtronic posterior annuloplasty band (serial number not provided) and mitral leaflet repair.The patient presented with dyspnea on exertion and echocardiogram revealed a flailing anterior leaflet.The band was explanted and was noted to incompletely endothelialized.The band was anchored at the right trigone and 2cm short of the left trigone.Subsequently, the neochordae inserted at the a2 scallop had ruptured in the middle.A 27mm medtronic mosaic bioprosthetic valve (serial number not provided) was implanted.The postoperative course was uneventful.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic engineers identified the 63 mm medtronic posterior annuloplasty band as model h607m63.The product information has been updated.

Manufacturer Narrative

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 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: 6674892
• MDR Text Key: 78652961
• Report Number: 2025587-2017-01055
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980534
• 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,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H607M63
• Device Catalogue Number: H607M63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR