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 Mitral Regurgitation (1964); No Code Available (3191)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

This event is being reported via the tvt registry.Exemption number e2019001.The device was not returned for analysis.Additionally, a review of the lot history records for the lots could not be conducted, because the lot numbers were not provided.The reported patient effect of mitral regurgitation is listed in the mitraclip system electronic instructions for use as known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effect, and the relationship to the device, if any, cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.The unique device identification (udi) is unknown as the part and lot numbers were not reported.

Event Description

This is being filed to report the unplanned surgery and increased mr.It was reported through transcatheter valve therapy (tvt) registry data that a mitraclip device may be related to adverse events which are considered serious injury.The relationship of the adverse events to the mitraclip devices could not be determined based on the data received from the registry.Reportedly, post procedure the patient underwent an unplanned cardiac surgery or intervention.Then 5 days post procedure, the patient was readmitted for a cardiac issue.At the first follow up, the mitral regurgitation (mr) was noted to be increased from post procedure.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: 9546586
• MDR Text Key: 177016832
• Report Number: 2024168-2020-00205
• 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: study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020

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: 12/13/2019
• Initial Date FDA Received: 01/03/2020
• 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
• Patient Age: 80 YR