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

Model Number	CDS0701-NTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/01/2023
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, and the reported single leaflet device attachment (slda) per the physician is related to patient conditions and due to friable leaflets and septal wall tissue.Unspecified tissue injury appears to be due to the slda.Tissue damage is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.The additional mitraclip devices referenced in b5 is being filed under a separate medwatch report number.
Event or Problem Description
This is filed to report incomplete coaptation and tissue damage.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3-4+ with an enlarged atrium and annulus.The first clip (30201r1020) was advanced into the patient.The leaflets were grasped and a leaflet tear was observed.The clip was then repositioned and implanted to treat the tear.A second clip (20607r114) was then implanted to further treat the leaflet tear.However, shortly after deployment of the second clip, it detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).Shortly after the slda occurred, the steerable guide catheter (sgc) was inadvertently pulled back into the right atrium (ra), resulting in a right to left shunt.The sgc was advanced back into the left atrium (la) and one additional clip was implanted to stabilize the slda.After removal of the sgc, an atrial septal defect (asd) closure device was implanted.The procedure was then concluded with a resulting mr of grade 3+.There was no clinically significant delay in the procedure and no additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17188048
• Report Number: 2135147-2023-02720
• Device Sequence Number: 17553382
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/22/2023

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: 06/07/2023
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 20607R114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 82 KG