MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that immediately following implant of this annuloplasty band in the tricuspid position, the sutures holding the band and holder were cut but the holder did not release.The band was cut in order to release the holder.The band was subsequently explanted.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The band is held in place by four retention sutures and the pins that are penetrated through the band cloth.No damage was found on the pins.Both guide sutures appeared to be cut.The flange on the returned holder was found to be intact.The holder appeared to open without difficulty.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Per the instructions for use (ifu), the flange retention suture shall be cut to remove the disposable flange and handle.The flange and handle shall be removed for better visualization.When the device is tied down all around the annulus and the holder retention sutures at the four locations are cut, the holder can be removed upwards by grasping the central bar.Grasping the central bar allows the holder pieces to separate and the pins to disengage/release the band.Overall, a true root cause to the reported difficulty could not be determined.No conclusion could be made from the image provided.A potential root cause for this event could be attributed to user technique.Grasping the central bar allows the holder pieces to separate and the pins to disengage/release the band.This investigation found no intrinsic evidence to suggest a manufacturing fault.

Manufacturer Narrative

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

• Brand Name: RING 620RG33 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5326724
• MDR Text Key: 34328751
• Report Number: 2025587-2015-01385
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Model Number: 620B
• Device Catalogue Number: 620BG33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2011
• 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