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

Catalog Number CDS0602-XTR

Device Problem Migration (4003)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from the lot.All information was investigated and based on the information provided, the reported migration (partial clip movement) appears to be due to procedural conditions.Foreign body in patient was due to the chordae being caught with the clip and therefore due to procedural conditions.The chordal rupture (tissue damage) appears to be due to the reported migration and thus related to procedural circumstances.Foreign body in patient and tissue damage are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The additional therapy/non-surgical treatment was a result of case-specific circumstances as an additional clip was implanted to stabilize the implanted clip.There is no indication of a product issue with respect to manufacture, design or labeling.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the clip grasping the chords and clip movement requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The clip delivery system (cds) was advanced and placed on the mitral valve.After deployment of the clip, it was noted the clip had moved and was not perpendicular to the valve and the clip moved on the leaflet.The physician suggested the chordae may have been caught with the clip as a chordal rupture was noted.A second cds was advanced although imaging was difficult due to the rotation of the first clip.The second clip was implanted to stabilize the first clip; however after deployment, the second clip detached from the anterior leaflet (single leaflet device attachment (slda)).A third clip was implanted to stabilize the slda clip.The procedure was completed at this time with the mr reduced to 3-4.Per the physician, the slda was due to the friable leaflets.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11323963
• MDR Text Key: 231690241
• Report Number: 2024168-2021-01164
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100009
• 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
• Report Date: 02/12/2021

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: 03/12/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00311U215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention