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 Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report after the mitraclip procedure, the atrial perforation had to be closed with an occluder.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade 4.Two clips were implanted.Left to right shunt and hypoxia was noted; therefore, an occluder was implanted successfully.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.A definitive cause for the reported patient effect of atrial perforation could not be determined in this case.A definitive cause for respiratory distress is also not confirmed in this case.Additional therapy/ non-surgical treatment was a result of case-specific circumstance as an occluder was implanted successfully.The patient effect of atrial perforation is listed in the instruction for use (ifu) as a known possible complication associated with mitraclip procedures.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.

• 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: 10427206
• MDR Text Key: 203708054
• Report Number: 2024168-2020-06923
• 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: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 53 YR