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

Model Number	CDS0701-NT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, the cause of the reported difficult to remove was unable to be determined.The reported unspecified tissue injury was a cascading event of the reported difficult to remove.The reported difficult leaflet grasping and poor image resolution were due to challenging patient anatomy.The reported patient effect of tissue injury as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was the 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 is filed under separate medwatch report number.
Event or Problem Description
This is filed to report difficulty retracting the clip causing tissue damage.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with a dilated left ventricle, and a restricted and cleft posterior leaflet.It was noted during the deployment process with the first clip (20615r185), a knot was found in the lock line.The lock line was removed from the opposite end without complication and the clip was deployed successfully.Shortly after, a small flail was noted.A second clip (20217r173) was then prepared and advanced into the patient to further reduce mr.Difficulty grasping was experienced so the physician elected to retract the clip back into the left atrium.At this time a larger flail was observed.It was suspected that there was chordal interaction with this clip when retracting into the left atrium.The clip was then implanted to treat the flail.It was also noted that the flail was attributed to the patient having friable and diseased tissue.The procedure was concluded with a resulting mr of grade 2+.There was no clinically significant delay in the procedure and no adverse patient sequelae.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: 16483097
• Report Number: 2135147-2023-01011
• Device Sequence Number: 7482167
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/03/2023

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: 02/16/2023
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20217R173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: Black Or African American