MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-NT

Device Problems Break (1069); Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted.To further reduce mr, an additional clip was inserted.During the start of the deployment steps, it was observed a leak was present on the clip introducer.The physician decided to proceed with deploying the clip.The clip was successfully implanted, reducing the mr to a grade of 1-2.After the procedure, it was observed that there was a crack on the flush port of the clip introducer.When unscrewing the stopcock, part of the flush port detached from the introducer.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported cracked and broken flush port luer were confirmed via returned device analysis.The reported leak could not be replicated in a testing environment.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 complaints reported from this lot.Based on available information and the returned device analysis, the reported leak appears to be a cascading event of the reported cracked flush port.The broken flush port appears to be related to post-procedural handling as the flush port broke when unscrewing the stopcock.The investigation determined the reported cracked flush port luer to be related to a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception.Therefore, exception (issue) 127621 and exception (action) 132488 are referenced.The investigation evaluated the reported issue, and the engineering group determined the potential root cause to be mother nature in the form of environmental stress cracking (esc).The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19060532
• MDR Text Key: 339788692
• Report Number: 2135147-2024-01585
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)240909(10)30911R1107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 30911R1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 85 KG