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 Pulmonary Embolism (1498); Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiac Tamponade (2226); Foreign Body In Patient (2687); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.D6 - the implant date is estimated.The additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.The devices were not returned for analysis and a review of the lot history record and similar complaint query could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, and due to limited information available from the article (no individual information available) and the article covering multiple patients, a cause for the reported expulsion could not be determined.Additionally, due to the limited information available, a cause for the patient effects of heart failure/congestive heart failure, pulmonary embolism, arrhythmia, cardiac tamponade, cerebrovascular accident, myocardial infarction (mi), hemorrhage and deaths could not be determined.Foreign body in patient however, is related to the clip detaching from both the leaflets (expulsion).However, foreign body in patient (dislodgement of previously implanted devices), heart failure, pulmonary embolism, arrhythmia, cardiac tamponade, cerebrovascular accident, myocardial infarction (mi), hemorrhage and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Surgical intervention and hospitalization were 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 research article was a prospective study designed to investigates the impact of transcatheter edge-to-edge repair (teer) in atrial functional mitral regurgitation (afmr) compared to other fmr etiologies.Complications identified in the study included: clip detachment, major bleeding, myocardial infarction, major or disabling stroke, pulmonary embolism, malignant arrhythmia, cardiac tamponade, device and access related complication requiring reintervention or urgent surgery.Cardiovascular death, all-cause death, hospitalization due to heart failure.In conclusion, the results of this giotto sub-analysis suggested that afmr is the least prevalent cause of fmr but associated with better clinical outcomes after teer compared to vfmr patients.Post-procedural mr>1+, peripheral vasculopathy, non-afmr etiologies were independent predictors of worse outcomes after teer with mitraclip.Details are listed in the attached article titled, "impact of transcatheter edge-to-edge mitral valve repair on atrial functional mitral regurgitation from giotto registry ".

• 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: 18221896
• MDR Text Key: 329168167
• Report Number: 2135147-2023-05230
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/28/2023

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: 11/08/2023
• Initial Date FDA Received: 11/28/2023
• 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; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male