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

Model Number CDS0701-XTW

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

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 05/17/2022

Event Type  Death  

Event Description

This report is being conservatively filed due to worsening heart failure and patient death, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with degenerative mitral regurgitation with a posterior leaflet prolapse.Two mitraclips were implanted without a device issue, reducing the mr to grade 1+ and 2+.On (b)(6) 2022, the patient was hospitalized for heart failure with shortness of breath.A pleural effusion was noted, and medications were provided.The patient was discharged home with hospice due to end stage heart failure.On (b)(6) 2022, the patient expired.Per physician, the event is unknown if device related.No additional information was provided regarding this issue.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported heart failure appears to be due to worsening of existing patient condition.The reported dyspnea, pleural effusion, tricuspid regurgitation, hypertension, and death appear to be cascading events of the heart failure.Additionally, heart failure, dyspnea, hypertension, and death are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization and medication were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B3: date of event updated.

Event Description

Subsequent to the previous report, the additional information was received: on 05/17/2022, during hospitalization for sepsis, worsening, severe tricuspid regurgitation was observed.On (b)(6) 2022, severe pulmonary hypertension was noted.Pulmonary artery pressure was up to 89mmhg.No treatment was provided.

• 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: 15698443
• MDR Text Key: 302682148
• Report Number: 2135147-2022-01835
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: 01/04/2023

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: 04/22/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10422R433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 63 KG