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

Model Number CDS0701-NT

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

Patient Problems Mitral Valve Stenosis (1965); Pleural Effusion (2010); Pulmonary Edema (2020); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and will not return.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed due to recurrent mitral regurgitation, with worsening heart failure, and kidney injury.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) grade 4+ with mitral annular calcification.One mitraclip was successfully implanted, reducing the mr to grade 1+.On (b)(6) 2021, the patient was hospitalized with fluid overload and worsening heart failure.Pulmonary edema and bilateral pleural effusions were noted.The mitraclip remained well attached with a moderate, eccentric, posteriorly directed regurgitation.Medications were provided as treatment.On (b)(6) 2021, the patient was hospitalized for an acute kidney injury (aki) and worsening heart failure, status post a fall.Medications were provided as treatment.Severe mr was noted, despite the implanted clip.There was no device malfunction specified, however, per physician, the device was inadequate, and did not reduce the mr as expected.No additional information was provided regarding this issue.

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 recurrent mitral regurgitation (mr) and mitral stenosis associated with elevated mean mitral valve gradient could not be determined.A cause of the worsening tricuspid regurgitation (tr) also could not be determined.The reported heart failure was due to worsening of existing condition.The reported pulmonary edema, pleural effusion and renal failure appear to be secondary to the heart failure.The reported patient effects of heart failure, mitral regurgitation, mitral stenosis, pulmonary edema and renal failure as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous report, the additional information was received/added: on (b)(6) 2021, during hospitalization for fluid overload, worsening tricuspid regurgitation was noted.The left atrium was dilated and mitral regurgitation persisted.The mitral valve gradient was elevated.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15986400
• MDR Text Key: 305501104
• Report Number: 2135147-2022-02554
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: 03/01/2023

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: 01/08/2022
• Device Model Number: CDS0701-NT
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 10108U180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 75 KG