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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event, implant date: estimated date (b)(6) 2019.The udi number is ¿ni¿ as the catalog number was not provided.Attached article, titled, pascal vs mitraclip for mitral valve transcatheter edge-to-edge repair: a single-center real-world experience.The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects and/or malfunctions reported in the article are captured under separate medwatch reports.

Event Description

This is being filed to report the clip detaching from one leaflet.This article is a prospective study of patients treated for mitral regurgitation (mr) with either the pascal or the mitraclip system at a university hospital between june 2019 and august 2021.Echocardiographic assessment was performed at discharge and during the 30-day follow-up.Technical success was achieved in both the pascal and mitraclip groups.Transcatheter edge to edge repair (teer) was safe in both groups, without occurrence of cardiac structural damage or conversion to open heart surgery.The occurrence of single-leaflet device attachment (slda) was low and observed in both groups and could be fixed with an implant of a second device during initial procedure.In-hospital mortality was low in both groups.Minor bleeding occurred in each group.At discharge, mr reduction was similar between the groups with a low degree of unchanged mr.At 1 month after teer, there was a high degree of sustained mr reduction in both groups, with low incidence of recurrent mr.Nyha functional class improvement was seen in a vast majority of patients.Therefore, complications included death, minor bleeding, unchanged mr, recurrent mr, slda (intraprocedure), and unexpected intervention (for implant of an additional clip).In this real-world registry, teer using the pascal or mitraclip repair system showed similar technical and procedural success.However, more long-term data in a multicenter randomized comparison with a larger number of patients is required.Specific patient information is documented as unknown.Details are listed in the attached article, titled, pascal vs mitraclip for mitral valve transcatheter edge-to-edge repair: a single-center real-world experience.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database for the reported lot could not be performed as the lot number and part number are unknown.Based on the information reviewed, and due to limited information available from the article the cause for the reported slda could not be determined.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 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: 14489642
• MDR Text Key: 295484045
• Report Number: 2024168-2022-05560
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/09/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/01/2022
• 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 Age: 79 YR