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

Model Number	CDS0701-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, the reported slda per the physician is related to patient conditions (prolapsed posterior leaflet).Unspecified tissue injury and mitral valve insufficiency/ regurgitation (unchanged) appear to be due to the slda.Mitral regurgitation and tissue injury/damage are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report single leaflet device attachment (slda).It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with a prolapsed posterior leaflet.An xtw clip was implanted with no reported issue.Another clip (xt) was implanted.After deployment of the xt clip, a single leaflet device attachment (slda) was observed.The clip had detached from the posterior leaflet.Chordae and tissue damage were noted.In the physician¿s opinion, the slda was due to the pre-existing patient anatomy.Additional clip (nt) attempted to correct mr.Slda clip was not considered unstable despite detaching from posterior leaflet.The additional clip did not reduce mr as intended so it was removed.Mr remained at grade 4.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Common Device Name: 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: 16885589
• Report Number: 2135147-2023-01982
• Device Sequence Number: 6092377
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20524R122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male