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

Catalog Number CDS0602-NTR

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 being filed to report the leak in the cds requiring aspiration.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.When inserting the clip delivery system (cds), air was drawn into the steerable guide catheter (sgc).Aspiration was performed.The cds was removed and since there were no more ntr devices available, a new clip introducer was taken from an xtr device and placed on the cds however the old clip introducer remained on the cds.The cds was then readvanced into the left atrium (la).The cds could not be successfully straddled as a few millimeters was missing therefore the physician decided to cut it off of the old introducer to make room.Unfortunately, there was still no space available so the physician decided to abort the procedure with the mr remaining at 4.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported leak was confirmed.Returned device analysis identified a tear in the silicone valve inside the clip introducer housing.A review of the lot history record revealed no manufacturing nonconformities for the reported lot.Additionally, a review of the complaint history did not indicate any similar incidents reported from this lot.It should be noted that the mitraclip instructions for use (ifu) states: inspect all clip delivery system parts, including the clip, to verify they are undamaged.Warning: do not use device if damage is detected.Use of damaged product may result in air embolism, device or device component embolization, vascular and/or cardiac injury.The failure to follow instructions did not contribute to the reported issues.A definite cause for the reported failure to advance could not be determined.The investigation determined the reported leak resulting from the observed torn material appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9642620
• MDR Text Key: 176835046
• Report Number: 2024168-2020-00970
• 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: 03/09/2020

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: 09/13/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 90914U142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention