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

Model Number CDS0701-XTW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  Injury  

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.Based on available information, the cause of the reported heart failure/congestive heart failure could not be determined.The reported test result (no treatment) was associated with low ejection fraction results.The reported patient effect of heart failure, 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.

Event Description

This report is being filed due to worsening heart failure, unknown if device related.(b)(4) expand phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient resented with chronic, ischemic mixed mitral regurgitation (mr) grade 4+ with posterior leaflet flail, significant cleft/scallop, and posterior ruptured chordae.Two mitraclips were successfully implanted, reducing the mr to trace.There was no device deficiency.On (b)(6) 2021, worsening heart failure was diagnosed by a decrease in the left ventricular ejection fraction (lvef) to 30%, compared to baseline above 50%.The event did not require additional hospitalization, and there was no treatment or intervention provided.Per physician, the event was unknown if device related.There was no device malfunction specified.No additional information was provided regarding this issue.

Manufacturer Narrative

Although the additional information would deem this event a non-complaint, since a report was already filed, the event remained reportable.Based on available information, there are no related effects to the clip delivery system.There remains no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previous combination report, the additional information was received: at the 6-month follow-up, the patient¿s ejection fraction was back to baseline, 55-59%.Per physician, the heart failure event is unrelated to the mitraclip device.There was no device malfunction.Although the additional information would deem this event a non-complaint, since a report was already filed, the event remained reportable.

• 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: 16609011
• MDR Text Key: 311959606
• Report Number: 2135147-2023-01329
• 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: 04/03/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10624R158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 82 KG