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

Model Number CDS0601-XTR

Device Problems Difficult to Remove (1528); Unintended Movement (3026); Material Split, Cut or Torn (4008)

Patient Problems Cardiac Tamponade (2226); Atrial Perforation (2511)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The steerable guide catheter referenced is filed under a separate medwatch report number.Na.

Event Description

This is filed to report torn material, difficult to remove, cardiac tamponade, surgical intervention, delay, and prolonged hospitalization.It was reported that this was a mitraclip procedure to functional mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc) was advanced to the mitral valve, and then the clip delivery system (cds) was advanced through the sgc.However, due to sleeve steering issues, the cds was retracted to be removed when it became stuck with sgc.Therefore, both the sgc and cds were removed as a single unit.After removal, the sgc tip was observed to be torn and the cds was torn at the shaft.This caused a clinically significant delay in the procedure as the patient experienced cardiac tamponade and a left arterial perforation.No clips were implanted, and mr is 4+.The patient remained hospitalized to undergo bypass surgery and pericardiocentesis for additional treatment.The patient is stable.As of (b)(6) 2020, the patient is stable.No additional information was provided.

Manufacturer Narrative

All available information was investigated and returned device analysis did not confirm the reported steering issues, clip delivery system (cds) shaft tear, or difficult to remove.A review of the lot history record revealed 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 incidents reported from this lot.Based on the information reviewed, a cause for the sleeve steering issue and difficult to remove could not be determined.The reported torn shaft appears to be due to user misperception as no issue was noted in the return device analysis.The atrial perforation and cardiac tamponade were outcomes of difficult to remove.Both atrial perforation and cardiac tamponade are listed in the instructions for use as known possible complications associated with mitraclip procedures.The additional therapy/non-surgical treatment, delayed therapy/non-surgical treatment, hospitalization, and surgical procedure were results of case specific circumstances.There is no indication of a 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: 10684383
• MDR Text Key: 211499815
• Report Number: 2024168-2020-08623
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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: 11/26/2020
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 91127U187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85