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

Catalog Number CDS0602-XTR

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 01/19/2021

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 user technique/procedural conditions.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 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 enlarged atrium and ventricle.The first clip delivery system (cds 00305u117) was advanced to the mitral valve, and the clip was deployed, reducing mr.Then a second cds (00603u189) was advanced to further reduce mr.However, during an attempt to grasp, the leaflets became entangled with the grippers.Using maneuvers to free the clip, the clip was then inverted and retracted back into the left atrium.The clip was then advanced into the left ventricle and grasping was performed.However, a sudden big jet was observed and a possible lesion between the a1-a2 scallops was detected.A decision was made to remove the cds with the clip attached.One clip was implanted, and mr is 4+.There was no clinically significant delay in the procedure.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: 11310342
• MDR Text Key: 231340243
• Report Number: 2024168-2021-01076
• 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: 02/10/2021

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: 06/03/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 00603U189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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
• Patient Outcome(s): Other