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

Model Number CDS0701-NTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Cardiac Enzyme Elevation (1838); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/08/2021

Event Type  Injury  

Event Description

This report is filed due to atrial fibrillation requiring treatment and mitral stenosis.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with mixed mitral regurgitation (mr) and a mitraclip procedure was performed.An ntw mitraclip was implanted without a device deficiency.On (b)(6) 2021, the patient was scheduled to have a watchman device implanted for new onset atrial fibrillation.On (b)(6) 2021, a follow-up echocardiogram was performed.Mild mr was noted along with a severely elevated mean mitral valve gradient.Atrial fibrillation persisted.Per physician, the events were possibly related to the mitraclip device.On (b)(6) 2021, the watchman device, and left atrial appendage (laa) closure devices were implanted.No additional information was provided regarding this issue.

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.

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.The reported patient effect of mitral stenosis is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported atrial fibrillation and mitral stenosis appear to be related to patient conditions.Furthermore, the hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

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.Based on the information reviewed, heart failure/congestive heart failure, cardiac enzyme elevation, atrial fibrillation, and mitral stenosis could not be determined.Heart failure/congestive heart failure, cardiac enzyme elevation, atrial fibrillation, and mitral stenosis are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.There remains no indication of a product issue with respect to manufacture, design, or labeling.H6: investigation conclusion code 50 removed.

Event Description

Subsequent to the previous reports, the additional information was received: on 08/03/2022, an elevated troponin level was noted and worsening heart failure was diagnosed.The event was possibly related to the mitraclip.There was no treatment and no additional hospitalization.

• 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: 13595785
• MDR Text Key: 288806380
• Report Number: 2024168-2022-02004
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10202U164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 02/24/2022; 08/08/2022
• Supplement Dates FDA Received: 03/18/2022; 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White