MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG35 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620B

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/09/2017

Event Type  Injury  

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 Description

Medtronic received information that immediately following implant of this annuloplasty band, this device was explanted and replaced.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was explanted and replaced with a bioprosthetic valve due to systolic anterior motion (sam) following its implant.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: RING 620RG35 DURAN ANCORE ANNULOPLASTY C
• 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: 6382486
• MDR Text Key: 69202302
• Report Number: 2025587-2017-00354
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• 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: 03/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2021
• Device Model Number: 620B
• Device Catalogue Number: 620BG35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided; 03/21/2017
• Supplement Dates FDA Received: 03/21/2017; 09/29/2017
• Date Device Manufactured: 09/21/2016
• 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: 62 YR