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

Catalog Number CDS0704-XTW

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

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for bibasilar crackers/atelectasis (pulmonary edema) and mitral valve insufficiency/ regurgitation (recurrent/mr) resulting in heart failure (including worsening heart failure, bnp elevation and jugular vein distention (jvd)) and dyspnea cannot be determined.Mitral regurgitation, dyspnea, heart failure and pulmonary edema are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This report is being filed due to recurrent mitral regurgitation and heart failure requiring intervention.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) grade 4+, with an enlarged right atrium and posterior leaflet flail.One mitraclip was successfully implanted, reducing the mr to grade 1+.On (b)(6) 2023, an echocardiogram was performed.Moderate eccentric mr with an elevated gradient at 5mmhg was noted.There was no mitral stenosis reported.On (b)(6) 2023, another follow-up echocardiogram was performed.Moderate to severe mr, along with posterior leaflet, p2 scallop prolapse was observed.On (b)(6) 2023 the patient was hospitalized with severe mr and worsening dyspnea over the last month.The patients heart failure lab - bnp was elevated and worsening heart failure was diagnosed.The patient was also noted in fluid overload with jugular vein distention (jvd) and bibasilar crackles/atelectasis.Diuretics were provided as treatment.The event resolved and the patient was discharged home.Per physician, the mitraclip remained stable and well seated and the p2 scallop prolapse was unrelated to the device.A device malfunction was not specified.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Surgical intervention was a result of case-specific circumstances.There remains no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6) 2023, a mitral valve repair with an open right mini-thoracotomy approach was performed.The subject was placed in intensive care unit on vasopressor (medication) support.

• 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: 16784774
• MDR Text Key: 313724361
• Report Number: 2135147-2023-01760
• 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: 05/25/2023

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: 10/03/2022
• Device Catalogue Number: CDS0704-XTW
• Device Lot Number: 11004R115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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): Disability; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White