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

Catalog Number CDS0702-XT

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

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 conservatively filed due to a patient death, unknown if device related.(b)(4) - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with degenerative mitral regurgitation (mr) grade 4+, with a large posterior leaflet prolapse with gap, mitral annular calcification, a significant cleft/scallop, posterior ruptured chordae, and a small mitral valve area.One mitraclip was implanted, reducing the mr to grade 1+ and 2+.There was no device deficiency.On (b)(6) 2023, the patient was found in her apartment and had expired.The event was unknown if device related.No additional information was provided regarding this issue.

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 unrelated death appears to be due to patient condition.Additionally, death is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previous report, the additional, downgrading information was obtained: on (b)(6) 2023, the patient expired due to a myocardial infarction (mi).Per physician, the death was unrelated to the mitraclip device.There was no device malfunction noted.Although with the additional information, this event would not be considered a reportable incident, since initial reports were already filed, a follow-up report is being reported.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17038792
• MDR Text Key: 316321079
• Report Number: 2135147-2023-02397
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: 12/01/2021
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 01201U150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 59 KG