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

Catalog Number UNK SGC03

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

Patient Problems Cardiogenic Shock (2262); Atrial Perforation (2511)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Dates estimated.(udi#): in the absence of a reported part number, the udi number cannot be calculated.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article attached: iatrogenic atrial septal defect following the mitraclip procedure: a state-of-the-art review.

Event Description

This is filed to report after the mitraclip procedure, the atrial perforation had to be closed with an occulder.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade 4.One clip was implanted.After the procedure, bidirectional shunt with dominant left to right shunt and a small end-diastolic right to left shunt and cardiogenic shock occurred.An occluder device was placed at the end of the mitraclip procedure.Details are listed in the attached article, iatrogenic atrial septal defect following the mitraclip procedure: a state-of-the-art review.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as lot and part number was not provided.Based on the information available, a definitive cause for the reported patient effects could not be determined.However, patient effects of atrial perforation and cardiogenic shock are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.Additional therapy/ non-surgical treatment was a result of case-specific circumstances as an occluder device was placed at the end of the mitraclip procedure.Although a conclusive cause for the reported patient effects 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.D1: brand name changed from unknown mitraclip to mitraclip® system steerable guide catheter d2.Product code changed from nkm to dra.D4.Catalog no.Changed from unk cds to unk sgc03.D6.Implant date removed.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10422383
• MDR Text Key: 203449946
• Report Number: 2024168-2020-06872
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR