MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Atrial Fibrillation (1729); Unspecified Infection (1930); Visual Disturbances (2140); Dizziness (2194); Nervous System Injury (2689)

Event Date 03/01/2019

Event Type  Injury  

Event Description

This is filed to report atrial fibrillation, delirium, stroke, seizures and hallucinations.The aim of this prospective monocentric study is to describe the various neurological complications after cardiac surgery or percutaneous valve replacement and to identify possible risk factors.297 patients with percutaneous valve replacement with a mitraclip procedure or cardiac surgery were postoperatively screened for neurological complications such as delirium, stroke, seizures and hallucinations twice daily for three days.Pre- and perioperative risk factors were evaluated in a multivariate model.The incidence of postoperative delirium after percutaneous valve replacement was between 0% to 44.6%.Patients with percutaneous valve replacement had a similar frequency of postoperative delirium (pod), but no acute ischemic stroke (ais), and no seizures in comparison to patients with cardiac surgery, although the patients with percutaneous valve replacement had a higher preoperative risk profile.Patients with neurological complications had in median significantly longer hospital stays.The median was 7 days for percutaneous valve replacement.A total of 7 patients experienced postoperative atrial fibrillation (af) and 10 patients experience hallucinations.Pod is the most frequent postoperative neurological complication in patients with cardiac surgery or percutaneous valve replacement.The results suggest that patients with neurological complications have a preoperative risk profile including older age, history of heart failure and cognitive impairment.But a complicated intra- and postoperative course with intense inflammatory response and diverse organ dysfunction might be a more important trigger for developing postoperative neurological complications.Details are listed in the attached article titled [e-129176 article], "stroke, seizures, hallucinations and postoperative delirium as neurological complications after cardiac surgery and percutaneous valve replacement.".

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

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 atrial fibrillation (no treatment), the reported nervous system injury (no treatment) / dizziness associated with delirium, the reported visual disturbances associated with hallucinations, the reported infection, and the reported hospitalization or prolonged hospitalization could not be determined.The reported patient effects of atrial fibrillation and infection, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A2: mean age a3: majority gender b3: date of event was estimated as 01 march 2019.D4: the udi is unknown as the part and lot numbers were not provided d6a: date of implant was estimated as (b)(6) 2019.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 15925897
• MDR Text Key: 304919839
• Report Number: 2135147-2022-02357
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/31/2023
• 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): Hospitalization; Other
• Patient Age: 74 YR
• Patient Sex: Male