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

Catalog Number CDS0704-XTW

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

Patient Problems Dyspnea (1816); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 06/07/2022

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.Based on available information, the cause of the reported mitral stenosis, the reported heart failure/congestive heart failure (treatment with medication(s)), the reported dyspnea (treatment with medication(s)), and the reported swelling/ edema, could not be determined.The reported tricuspid regurgitation (disease progression) was associated with worsening tr from disease progression.The reported mitral regurgitation (disease progression) was associated with disease progression in conjunction with poor compliance with medication intake/ diet on the patient¿s part.The reported patient effects of mitral stenosis, mitral regurgitation, heart failure, dyspnea, edema, and tricuspid regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required 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

This report is being filed due to mitral stenosis and worsening heart failure.Crd_947 - repair mr ide study patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with mitral annular calcification and p2 flail.Two mitraclips were successfully implanted, reducing the mr to grade 1+ on (b)(6) 2022, mitral stenosis was diagnosed on a follow-up echocardiogram.On (b)(6) 2023, the patient presented for their one-year follow-up.Shortness of breath, dyspnea, using 2-3 pillows to sleep, significant edema, and worsening congestive heart failure was diagnosed.Reportedly, the clips remained stable and well seated.There was no device related tissue injury observed.The worsening tr was related to volume overload and recurrent mr was due to the patients poor compliance with sodium and fluid intake, as well as adherence to diuretic therapy.The worsening tr and recurrent mr were deemed due to disease progression.The worsening heart failure was possibly device related.Medications were optimized by the cardiologist.The patient was instructed on a low salt diet and elevation of lower extremities to aid with edema.Surgery is possible in the future.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous report, the additional information was received: on 07/31/2023, a mitral valve replacement was performed.

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 available information, the cause of the reported hospitalization and surgery were results of case-specific circumstances.There remains no indication of a product quality 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: 17039530
• MDR Text Key: 316393269
• Report Number: 2135147-2023-02398
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Report Date: 08/25/2023

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: 01/23/2023
• Device Catalogue Number: CDS0704-XTW
• Device Lot Number: 20120R101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White