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

Catalog Number CDS0706-XTW

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

Patient Problems Atrial Fibrillation (1729); Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 09/20/2023

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 is filed to report atrial fibrillation and hematoma.(b)(6).Repair mr ide study, patient id: (b)(6).It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was stated the patient was unable to be anticoagulated due to a right groin hematoma.One clip was successfully implanted, reducing mr.After the procedure, the patient experience atrial fibrillation and hypotension.For treatment, medications were administered.The following day, cardioversion was successfully performed.No additional information was provided.

Event Description

(b)(6) - repair mr ide study.Patient id: (b)(6).Subsequent to the initial report, the additional information was received: it was reported that on (b)(6) 2023, the patient presented with degenerative mitral regurgitation (mr) grade 4+ with an enlarged left atrium and posterior leaflet flail.Two mitraclips (cds0706-xtw, 30607a2019 and 30308r2103) were successfully delivered and deployed.Per physician, the atrial fibrillation and tachycardia events were unrelated to the mitraclip device.There was no hypotension reported.The right groin hematoma was possibly related to the mitraclip device.There was no unplanned hospitalization and no treatment for the hematoma.

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.The investigation was unable to determine a cause for the reported hematoma.Hematoma is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no intervention performed to address the hematoma.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18012536
• MDR Text Key: 326626821
• Report Number: 2135147-2023-04676
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 01/08/2024

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 Catalogue Number: CDS0706-XTW
• Device Lot Number: 30607A2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 01/07/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White