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

Catalog Number	CDS0601-NTR
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+.A ntr (lot: 31122r1074) was chosen for implantation utilizing steerable guide catheter (sgc)(lot: 31207r1052).The patient presented with posterior leaflet p3 prolapse and pre-existing chordal rupture.The ntr was attempted to be placed a3/p3, but due to the posterior leaflet motion, grasping was difficult.After multiple attempts the ntr was able to grasp and was implanted.After implantation a perforation of the posterior leaflet was observed.Mr increased to grade 4+.A second xtr clip (lot: 40102r1026) was attempted but was not implanted without device issue.The patient was sent to cardiac surgery.The physician though the sgc could not give enough supporting strength and had some problems.
Additional Manufacturer Narrative
All available information was investigated, and the reported difficult leaflet grasping could not be replicated in a testing environment.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 complaints reported from this lot.Based on available information, the reported difficult leaflet grasping was due to challenging patient anatomy (posterior leaflet motion).The cause of the reported tissue injury was unable to be determined.The reported unchanged mr was likely a cascading effect of the reported tissue injury.The reported patient effects of tissue injury and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical intervention, and surgical intervention were results 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: 19617856
• Report Number: 2135147-2024-03050
• Device Sequence Number: 20573696
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)241121(10)31122R1074
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/16/2024

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: 11/21/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 31122R1074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian