MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NT

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 01/21/2021

Event Type  Injury  

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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, the reported difficult to remove appears to have been a result of challenging patient anatomy.The reported tissue damage appears to have been a cascading event of the reported difficult to remove.The reported patient effect of tissue damage as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report difficult to remove and tissue damage it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted calcium shelf on the posterior annulus and medial posterior leaflet tethering.The ventricle was chord rich in areas away from a2/p2.The first two clips were successfully deployed.Then a third clip delivery system (cds 00803u259) was advanced into the left ventricle, but when the clip was opened, the clip immediately became stuck in the chords.With standard troubleshooting, the clip was able to be freed and returned to the left atrium.However, torn chords and a slight posterior flail segment was observed.The cds was removed with the clip attached.Additional treatment was not performed.A decision was made to abort the procedure.The first clip and the second clip (01120u145 ) remain stable on both leaflets.Two clips were implanted, and mr is 4.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 11314474
• MDR Text Key: 231391332
• Report Number: 2024168-2021-01102
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/11/2021

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: 08/03/2021
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 00803U259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: 2 IMPLANTED MITRACLIPS; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 58