MAUDE Adverse Event Report: ABBOTT VASCULAR 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); Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104); Heart Failure (2206)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, a cause for the reported tissue damage cannot be determined.The reported mitral regurgitation resulted in dyspnea, atrial fibrillation and heart failure; however, are related to the tissue damage.Tissue damage, dyspnea, atrial fibrillation, heart failure and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The additional therapy/non-surgical treatment and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report post mitraclip procedure, tissue damage, atrial fibrillation, heart failure and recurrent mitral regurgitation occurred.It was reported that the initial mitraclip procedure was performed in (b)(6) 2017 to treat degenerative mitral regurgitation (mr) with a grade of 4+.Two clips were implanted, reducing the mr to 2.On (b)(6) 2021, the patient presented with dyspnea, atrial fibrillation and heart failure.A control echocardiogram was performed, found the clips stable with no evidence of a single leaflet device attachment but there was a chordae rupture on the p2 leaflet and residual mr at the rupture level.On (b)(6) 2021, an additional clip was implanted lateral to the previous 2 clip implants, reducing mr from 4 to 1.The procedure was successful.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11286571
• MDR Text Key: 230505344
• Report Number: 2024168-2021-00905
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2021

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: 01/13/2021
• Initial Date FDA Received: 02/05/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention