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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average.Sex: majority.Date of event and implant date: estimated.The additional patient effects referenced in are filed under a separate medwatch report number.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article attached: "hemodynamic profiles and clinical response to transcatheter mitral repair".

Event Description

This research article was a meta-analysis study designed to examine the relation between hemodynamic profiles and outcomes following mitral transcatheter edge-to-edge repair (teer).Complications identified in the study included: death, mitral surgery, heart failure rehospitalization, myocardial infraction, stroke, transient ischemic attack, bleeding.In conclusion, patients undergoing mitral teer, hemodynamic profiling is prognostic, with superior survival occurring among patients with optimal reduction in mitral regurgitation and normal postprocedural left atrial pressure (lap).Details are listed in the attached article titled, "hemodynamic profiles and clinical response to transcatheter mitral repair".

Manufacturer Narrative

The products were not returned for analysis.The lot history record (lhr) review and similar complaint review were not performed because this complaint was based on a review article, and no device/lot information was provided.Based on available information and due to the limited information available from the article and the article covering multiple patients, a cause for the reported transient ischemic attack, death /expired, hemorrhage, cerebrovascular accident (stroke), heart failure/congestive heart failure, and myocardial infarction cannot be determined.Transient ischemic attack, death /expired, hemorrhage, cerebrovascular accident (stroke), heart failure/congestive heart failure, and myocardial infarction are listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 15481524
• MDR Text Key: 300575770
• Report Number: 2135147-2022-01358
• Device Sequence Number: 1
• Product Code: NKM
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/24/2022
• 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; Required Intervention; Disability
• Patient Age: 82 YR
• Patient Sex: Male