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

Catalog Number CDS0702-XTW

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 04/09/2024

Event Type  Death  

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 Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 3.A mitraclip xtw was inserted and advanced to the mitral valve.However, while applying half a turn of the m knob, resistance occurred, and the clip stopped maneuvering.An echocardiogram was performed and revealed a pericardial effusion.Upon further investigation, a perforation of the lateral atrial wall, due to the clip, was observed.The clip could not be retracted from the tissue in the atrium.Emergency surgical intervention was performed, and the clip was freed and removed from the patient.Pericardiocentesis was performed and the procedure was discontinued.The mr remained at a grade of 3 and the patient was transferred to heart surgery.While undergoing surgical intervention, the patient died.In the physician's opinion, the bleeding caused by the pericardial damage contributed to the patient death.

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, a failure analysis of the complaint device could not be performed because the product 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.The event was further reviewed by an abbott senior director of medical affairs.Based on available information, the reported physical resistance and perforation appear to be related to procedural conditions (interaction with cardiac tissue).The reported pericardial effusion and death appear to be results of the perforation.Additionally, the reported patient effects of pericardial effusion, perforation, and death are listed in the mitraclip system instructions for use (el2204011, revision, a, potential complications and adverse events section), and are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and unexpected medical intervention were results of case-specific circumstances as surgery was attempted to treat the perforation.

• 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: 19214124
• MDR Text Key: 341402317
• Report Number: 2135147-2024-01911
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)250108(10)40109R1058
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/23/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 40109R1058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2024
• 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): Death