MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported a mitraclip procedure was being performed to treat degenerative mitral regurgitation (mr) with a grade of 3-4 and a p2 flail.An xtw clip was deployed and it was noted that the clip had perforated the posterior leaflet and was slightly angled with a slight rocking motion.A second clip was used due to the perforation.A nt clip was advanced into the anatomy, grasping was performed and reduced mr, however the physician wished to try another grasp to further reduce mr.Upon regrasping, it was noted that mr had increased.It was additionally noted that this clip was trapped in chordae, it was able to be removed but noted to have been difficult.The clip was removed from the patient anatomy.Two additional xtw clips were attempted to be placed.Multiple grasping attempts and clip manipulation appeared to cause further damage to the mitral leaflets and the severity of the mr increased.The mr increased to 3+ after the first clip was used, and to 4+ after the second clip used.These events resulted in the patient being hemodynamically unstable, experiencing tachycardia and a drop in blood pressure.An iabp was inserted and they were converted to surgery.
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.Based on available information, the cause of the reported perforation, recurrent mr, tachycardia, and hypotension were unable to be determined.The reported patient effects of tissue injury, mitral regurgitation, and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP
• 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: 20363556
• Report Number: 2135147-2024-04868
• Device Sequence Number: 20550217
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)240913(10)30914R1032
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 10/24/2024

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: 09/13/2024
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 30914R1032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown