MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/11/2024

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.Based on available information, the cause of the reported perforation was unable to be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

It was reported a mitraclip procedure was performed to treat functional mitral regurgitation (mr) and tricuspid regurgitation (tr) with a grade of 5+.A steerable guide catheter (sgc) was inserted and three clips were successfully deployed on the mitral valve without issues.The sgc was then retracted into the right atrium (ra) and one mitraclip was deployed on the tricuspid valve.However, after deployment, it was suspected the clip detached from the anterior leaflet and remained attached to the septal leaflet (single leaflet device attachment/slda).Tr was reduced to a grade of 3-4 and no additional treatment was performed.After removal of the sgc, a left to right shunt was observed.Therefore, an atrial sept defect (asd) closure device was implanted.No clinically significant delay in the procedure.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• 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: 18580249
• MDR Text Key: 333734035
• Report Number: 2135147-2024-00353
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• 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: 01/25/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 31101R1090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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 (X4)
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG