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); Perforation (2001); Transient Ischemic Attack (2109); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This is filed to report heart failure, atrial septal defect, recurrent mitral regurgitation (mr), hemorrhage, surgical valve replacement, additional clip intervention, prolonged hospitalization, embolism (for clip migration), stroke, transient ischemic attack, and myocardial infarction.This was a single-center, retrospective analysis of consecutive patients referred to a second mitral transcatheter edge-to-edge repair (teer) after a technically successful first procedure.A total of 52 patients (median age, 81, majority men, 50 percent with functional mitral regurgitation (mr)) met the inclusion criteria.Teer procedures performed on adult patients between (b)(6) 2013, and december 31, 2020.Mr recurrences were mostly related to progression of the underlying cardiac pathology, but some patients did experience recurrent mr from migration, loss of leaflet insertion, and leaflet detachment.Fourteen patients died or were hospitalized due to heart failure (hf).Two patients developed a post-procedural mild bidirectional shunt.One patient required a surgical valve replacement.Two patients had a bleeding episode and two had a cardiovascular event (including stroke, transient ischemic attack, and myocardial infarction).All redo procedures were concluded by successful device deployment, without intraprocedural complications or conversion to surgery.Details are listed in the attached article titled, "repeat mitral transcatheter edge-to-edge repair for recurrent significant mitral regurgitation.".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and a review of the complaint history could not be performed as this complaint is based on an article review, and lot/device information is not available.The reported mr appears to be due to disease progression.Causes for the reported heart failure, atrial perforation, cerebrovascular accident, tia, embolism, hemorrhage, and mi could not be determined additionally, mr, heart failure, atrial perforation, cerebrovascular accident, tia, embolism, and mi are listed in the ifu as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, surgical intervention, and hospitalization were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.A2: mean age.A3: majority gender.B3: date of event was estimated as (b)(6) 2013.D4: the udi is unknown as the part and lot numbers were not provided.D6a: date of implant was estimated as (b)(6) 2013.Literature attachment: article e-160083na.

• 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: 17106240
• MDR Text Key: 316953518
• Report Number: 2135147-2023-02513
• 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
• Report Date: 06/12/2023

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/12/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male