MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDING CATHETER; VALVE REPAIR

Catalog Number UNK SGC03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

This will be filed as a serious injury summary report per fda exemption approval number - e2015009.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.Based on the limited information reviewed, a cause for the reported atrial perforation events could not be determined.The reported patient effect of atrial perforation, as listed in the mitraclip instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 32 atrial septal defect requiring intervention events which is considered a serious injury.The relationship of the adverse events to the mitraclip device could not be determined based on the limited data received from the registry.Patients¿ mean age 73 years, ranging from 30 - 90 years.72% patients were male, 28% patients were female.Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDING CATHETER
• 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: 11015281
• MDR Text Key: 222089424
• Report Number: 2024168-2020-10542
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• 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: 72 YR