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

Catalog Number CDS0602-XTR

Device Problem Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the clip movement and leaflet damage requiring intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.After deployment of the second clip, it was noted the mr increased.The posterior mitral leaflet (pml) was torn and the moved position.A third clip was implanted to stabilize the second clip, reducing mr to 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not identify any similar complaints.Based on the available information, a cause for the reported migration (partial clip movement) could not be determined.The reported tissue damage was a result of the reported migration (partial clip movement).The reported patient effect of tissue damage (mitral valve injury) is included in mitraclip ntr/xtr system instructions for use (ifu), as a known possible complication associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

• 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: 11296520
• MDR Text Key: 230924528
• Report Number: 2024168-2021-00967
• 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: 04/02/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00313U104
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention