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

Catalog Number CDS0705-NT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/04/2024

Event Type  Injury  

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 complaints reported from this lot.Based on available information, the cause of the reported difficult leaflet capture and tissue injury were unable to be determined.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 serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat a mixed mitral regurgitation (mr) with grade of 4 and prolapsed posterior (p3) leaflet.During an attempt to fully close the nt clip after grasping a3/p3 lateral, a loss of leaflet capture was observed on the posterior leaflet.This caused a tear of the posterior leaflet.The clip was then repositioned to grasp a3/p3 medial, reducing mr to grade 1-2.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: 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: 18977748
• MDR Text Key: 338586072
• Report Number: 2135147-2024-01336
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288616
• UDI-Public: (01)08717648288616(17)240322(10)30324R1041
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Catalogue Number: CDS0705-NT
• Device Lot Number: 30324R1041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 58 KG