MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report an unstable arm positioner.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 3-4.One clip was successfully implanted.To further reduce mr, a second clip delivery system (cds) was attempted to be prepped; however, during when the packaging was opened, the arm positioner was noticed to have slipped out of the delivery catheter (dc) handle.The device was unable to be used; therefore, it was replaced with an additional cds.One more clip was implanted, reducing mr to a grade of 1-2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis did not confirm the reported unstable (arm positioner).However, the arm positioner was noticed to be tilted and there was a gap between the arm positioner and the delivery catheter (dc) handle.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.The investigation determined that the observed tilted arm positioner appears to be related to a potential product issue.The reported unstable arm positioner also appears to be related to the potential product issue.The investigation is still on going and additional actions will be taken if warranted; and will be documented per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10448838
• MDR Text Key: 204217811
• Report Number: 2024168-2020-07068
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00219U184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1