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

Catalog Number CDS0705-NTW

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)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

A2 and a4: patient demographics were obtained from baseline data.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 heart failure, mitral stenosis, and dyspnea were unable to be determined.The reported patient effects of dyspnea, mitral stenosis, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical intervention, and medication required were results 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_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6) it was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) with dilated cardiomyopathy, and leaflet tethering.The patient has pre-existing renal failure requiring dialysis.One mitraclip was implanted, reducing the mr to grade 1+.Starting post-procedure, an elevated mean mitral valve gradient was noted.Mitral stenosis was diagnosed.On (b)(6) 2022, worsening heart failure was noted.On (b)(6) 2022, the patient had been admitted to the hospital with heart failure and dialysis was performed to remove extra fluid.Reportedly, the patients diet was not salt restricted, and the patient was not compliant with medications.As a result, his heart failure had worsened.A salt restricted diet was initiated, and medications were also provided as treatment.The event was not related to a device malfunction.On (b)(6) 2022, after hospitalization with covid-19 pneumonia, the patient had been hospitalized again in fluid overload and worsening heart failure.Dyspnea was also noted.Dialysis was performed and medications provided.A bacterial mrsa infection develop due to severe itching and scratching of the skin, treated with antibiotics.On (b)(6) 2022, the patient was admitted to the hospital again in fluid overload and worsening heart failure.Reportedly, they were unable to remove enough fluid during dialysis due to the patient becoming hypotensive.Dialysis was performed again, and medications were provided.The event resolved.

• 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: 19042378
• MDR Text Key: 339434422
• Report Number: 2135147-2024-01523
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 10614R107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 80 KG