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

Catalog Number CDS0701-NTW

Device Problem Leak/Splash (1354)

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

Event Date 02/13/2024

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.

Event Description

It was reported this was a mitraclip to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted without issues.However, when the clip delivery system (cds) was inserted into the sgc hemostatic valve, air was observed in the sgc.This occurred multiple times; therefore, the sgc and cds were removed and replaced.It was noted the leak was more than likely caused by the cds.One clip was then successfully implanted, reducing mr to a grade of <1.There was no clinically significant delay in the procedure.

Manufacturer Narrative

All available information was investigated, and the reported leaking clip introducer was confirmed via returned device analysis.Additionally, a torn clip introducer valve and missing silicone fluid were observed.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/splash was a cascading event of the observed torn clip introducer valve.The investigation determined the observed torn clip introducer valve and missing silicone fluid to be related to a potential product quality issue.The reported unexpected medical intervention was a result of case-specific circumstances.Per (b)(4), revision f, 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) 126748 and exception (action) 131415 are referenced.The investigation evaluated the reported issue, and the engineering group determined the root cause to be man for the missing silicone and therefore, the torn clip introducer valve as the operators inadvertently missed the silicone verification.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 (MDD)
• 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: 18839796
• MDR Text Key: 336957276
• Report Number: 2135147-2024-01001
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: (01)08717648230967(17)240627(10)30629R1032
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Catalogue Number: CDS0701-NTW
• Device Lot Number: 30629R1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention