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

Catalog Number CDS0702-NTW

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, prolapsed anterior leaflet, pre-existing flail (chordal rupture) in the anterior leaflet in centro-medial region.A steerable guide catheter and a mitraclip ntw were inserted without issues.However, while steering the clip, the tip interacted with the marshall rift/ligament.The steerable guide catheter was retracted, and the issue was resolved.However, a pericardial effusion and imminent tamponade was observed.To treat the pericardial effusion, a pericardiocentesis was performed, and the procedure was aborted.The mr remained at a grade of 4.Surgical intervention was performed to treat the small tear at the medial roof of the left atrium (la).It was noted that the left appendix appeared to be intact, and the patient was alive and recovering from surgery the day after the procedure.In the physician¿s opinion, no abbott device caused or contributed to the pericardial effusion, and the small laceration during transseptal puncture may have become a tear while performing the steering maneuvers, and abnormal septal anatomy and frailty of the tissues may have contributed to the event.

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.

Manufacturer Narrative

The device was not returned.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 from the lot.All available information was investigated, and a cause for the reported difficult or delayed positioning with anatomy, perforation, pericardial effusion and cardiac tamponade cannot be determined.Perforation, pericardial effusion and cardiac tamponade are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.Unexpected medical intervention, surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 18997453
• MDR Text Key: 338879652
• Report Number: 2135147-2024-01385
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230974
• UDI-Public: (01)08717648230974(17)240509(10)30510R2033
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30510R2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female