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

Model Number CDS0701-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Swelling/ Edema (4577)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

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 and a single leaflet device attachment.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with degenerative mitral regurgitation (mr) with a posterior leaflet prolapse, mitral annular and leaflet calcification.One mitraclip (cds0701-ntw, 10301r186) was implanted without a device issue, reducing the mr to grade 2+.On (b)(6) 2021, a follow-up echocardiogram was performed, and the mr increased to grade 3+.On (b)(6) 2022, another follow-up echocardiogram was performed, and the mr had increased to grade 4+.Reportedly, the clip had a single leaflet device attachment (slda).No additional information was provided regarding this issue.

Event Description

Subsequent to the initial report, the additional information was received: in the physicians opinion, the single leaflet device attachment was due to patient anatomy.There was no known tissue injury.No additional treatment was provided.

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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, the cause of the reported mitral valve insufficiency/regurgitation (recurrent mr) associated with the increase in mr was due to the single leaflet device attachment (slda).The cause of the reported incomplete coaptation (postprocedure) associated with the slda due to challenging patient anatomy (posterior leaflet prolapse, annular calcification, and leaflet calcification).The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality 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.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, the reported mitral valve insufficiency/ regurgitation (recurrent mr) associated with the increase in mr, the reported dyspnea (treatment with medication(s)), the reported hypertension (treatment with medication(s)), the reported swelling/ edema associated with the weight gain, the reported syncope/fainting, and the reported heart failure/congestive heart failure (treatment with medication(s)), appear to be due to the single leaflet device attachment (slda).The reported incomplete coaptation (postprocedure) associated with the slda was due to challenging patient anatomy (posterior leaflet prolapse, annular calcification, and leaflet calcification).The reported patient effects of mitral regurgitation, dyspnea, edema, hypertension, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization and medication required were results of case-specific circumstances.There remains no indication of a product quality issue with respect to manufacture, design, or labeling.H6 health effect - impact code 4614 removed.

Event Description

Subsequent to the previous report, the additional information was received: on (b)(6) 2022, the patient started experiencing shortness of breath on exertion and weight gain.On (b)(6) 2022, the patient had a syncopal episode.On (b)(6) 2022, the patient was hospitalized with continued weight gain and shortness of breath on exertion, worsening congestive heart failure was diagnosed.Pulmonary hypertension was noted.Diuretic medications and additional medications were provided, including for the flu.The patient has been discharged from the hospital.

Manufacturer Narrative

A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The cause of the reported tricuspid valve insufficiency/ regurgitation (worsening tr) could not be determined.There remains 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: on (b)(6) 2022 worsening tricuspid regurgitation was diagnosed.Reportedly, the worsening tr was due to the device deficiency.

• 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: 15599119
• MDR Text Key: 301724069
• Report Number: 2135147-2022-01611
• 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,Followup
• Report Date: 05/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10301R186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/26/2022; 01/26/2023; 04/10/2023
• Supplement Dates FDA Received: 11/18/2022; 02/20/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 73 KG