MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Cardiogenic Shock (2262); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/07/2022

Event Type  Death  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a patient death.It was reported that the patient underwent a mitraclip procedure on (b)(6) 2021 to treat functional mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted, reducing the final mr to a grade of 2.On (b)(6) 2022, the patient was admitted to the hospital due to syncope.A right heart catheterization was performed and x-ray revealed that the implanted clip opened.No damage was noted, and the clip remained stable and attached to both leaflets.The patient¿s mr grade was rated severe and the patient had a low ejection fraction (ef).The patient died on (b)(6) 2022 due to severe heart failure and cardiogenic shock.The physician stated that the patient¿s symptoms and heart failure were related to the increased mr.No additional information was provided.

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.The recurrent mitral regurgitation (mr) appears to be related to the reported clip open while locked.The syncope, shock, heart failure and subsequent death appear to be related to the recurrent mr.The reported hospitalization was a result of case-specific circumstance.Mr, syncope, shock, heart failure and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The investigation determined the reported clip open while locked appears to be related to a potential quality product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.This event was further reviewed by an abbott global medical affairs director and the reviewer stated ¿in this case of grade 4 functional mitral regurgitation, the patient underwent a mitraclip procedure on (b)(6) 2021.One clip was successfully implanted, reducing the final mr to a grade of 2.On (b)(6) 2022, the patient was hospitalized due to syncope.X-ray revealed that the implanted clip opened.No damage was noted, and the clip remained stable and attached to both leaflets.The patient¿s mr grade was rated severe.Patient had a low ejection fraction (ef) and was medically treated.The patient died sometime between (b)(6) 2022 and (b)(6) 2022 due to severe heart failure and cardiogenic shock.The physician stated that the patient¿s symptoms and heart failure were related to the increased mr.There is no evidence that death was related to the device but increased mr post-procedure likely triggered a cascading effect on worsening heart failure leading to death.¿ this event was further reviewed by a clinical staff engineer research & development, and the reviewer stated that ¿one (1) fluoroscopic video and one (1) fluoro still image was provided at the following denoted time points: (b)(6) 2021 (procedure date) and (b)(6) 2022 (follow up date).In total, four (4) fluoroscopic cine were provided.The (b)(6).2021 fluoro shows the fully deployed clip which appears to be fully closed (~10°) per the instructions for use.The (b)(6) 2022 fluoro shows the same clip but with apparent opening of the clip arms, as compared to the state of the clip (fully closed ~10°) post procedure in (b)(6) 2021.Based on a visual examination with the naked eye, the clip arm angle in the follow up fluoro from (b)(6) 2022 appears to be ~60°.However, this is only a best approximation and cannot be confirmed.Based on the fluoro cine provided, it is evident that the clip arms opened an unconfirmed amount as compared to post procedure in (b)(6) 2021.¿.

Event Description

N/a.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13951646
• MDR Text Key: 288212001
• Report Number: 2024168-2022-03336
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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 Expiration Date: 05/25/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10525R149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female