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); Positioning Failure (1158)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	03/22/2023
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 identified no similar complaints.All available information was investigated, and the reported positioning failure associated with leaflet grasping and capturing and difficult or delayed positioning associated with positioning the device in the anatomy appears to be related to patient conditions (lv anuerysm).Image resolution poor is related to patient and procedural conditions as it was reported that imaging was difficult due to the lv aneurysm (anatomy).Unspecified tissue injury resulting in mitral valve insufficiency/ regurgitation (unchanged) appears to be related to the procedural conditions associated with difficult leaflet grasping/capturing.Tissue damage and mitral regurgitation are 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 tissue damage it was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of a 4+.It was noted a left ventricle (lv) aneurysm made imaging.Two clips were deployed on the mitral valve, reducing mr to a grade of 1-2.A third clip (20504r141) was inserted, and grasping was performed.However, due to the lv aneurysm, posterior position and was difficult, resulting in difficult grasping and capturing the leaflets.It was then observed the tissue damage on the posterior leaflet occurred, causing mr to increase to a grade of 3-4.Therefore, the clip was removed and replaced.A fourth clip (20613r144) was inserted and deployed on the mitral valve.It was noted that due to imaging, grasping was difficult.After deployment, it was observed mr had increased to a grade of 4+.The physician stated the fourth clip did not cause any tissue damage and the mr returning to a grade of 4+ was due to the damage caused by the third clip.The decision was then made to to discontinue the procedure.There was no clinically significant delay in the procedure.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: 16669897
• Report Number: 2135147-2023-01461
• Device Sequence Number: 12243384
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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: 05/04/2023
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20504R141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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 (X2); STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 115 KG