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

Model Number CDS0701-NTW

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

Patient Problems Dizziness (2194); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 07/14/2022

Event Type  Death  

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 worsening heart failure, organ failure, and patient death.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with severe degenerative mitral regurgitation (mr) with posterior leaflet prolapse.One mitraclip clip was implanted, reducing the mr to grade 1+ and 2+.On (b)(6) 2022, the patient presented to the emergency room with complaints of dizziness and a fall at home.Anasarca (generalized swelling-edema), and malnutrition were noted.Multisystem-organ failure and congestive heart failure were diagnosed.Paracentesis was performed as treatment and the patient was placed in palliative care.There was no hospitalization.On (b)(6) 2022, the patient expired.Per physician, the event was unknown if device related.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because no lot information was provided.Based on available information, the cause of the reported swelling/ edema, dizziness, multiple organ dysfunction syndrome (dysfunction), heart failure/congestive heart failure, and death / expired (cardiac death) could not be determined.The reported patient effects of edema, death, heart failure, and system organ failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention 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

Nab2: date of death corrected.

Event Description

Subsequent to the previous report, the additional, corrected information was received: on (b)(6) 2022 the patient had expired.

• 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: 15779619
• MDR Text Key: 303534178
• Report Number: 2135147-2022-02040
• 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
• Report Date: 02/19/2023

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 Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 02/12/2023
• Supplement Dates FDA Received: 01/06/2023; 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 54 KG