MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number	CDS0601-NTR
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+ and a posterior prolapse.A steerable guide catheter (sgc) and an ntr clip were inserted, and multiple grasping attempts were performed.However, a tear to the anterior leaflet was observed, resulting in a clinically significant delay in the procedure.Therefore, the sgc and clip were removed, and the procedure was discontinued.Mr remained at grade of 4+.It was noted a tear to the soft tip of the sgc was observed.There was no clinically significant delay in the procedure.
Additional 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 additional mitraclip device referenced in b5 is being filed under a separate medwatch report.
Additional Manufacturer Narrative
All available information was investigated and the reported positioning failure of inability to capture the leaflets could not be replicated in a testing environment as they were related to patient and/or procedural conditions.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 did not indicate a lot-specific quality issue.The investigation determined the reported inability to capture appears to be due to the reported tissue injury (torn anterior leaflet).The tissue injury appears to be due to multiple grasping and capturing attempt.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported delay to treatment/ therapy was a result of case specific circumstance as the tear to the anterior leaflet was observed, resulting in a clinically significant delay in the procedure.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.H6: code 2993 was removed.
Event or Problem Description
Subsequent to the initially filed report, additional information was received stating the clip was unable to capture the leaflets.After the sgc was removed, deformation to the soft tip of the sgc was also observed.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• 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: 18777742
• Report Number: 2135147-2024-00857
• Device Sequence Number: 14538654
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30623R1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian