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

(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: 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 degenerative mitral regurgitation (mr) with grade 3-4.Two clips were implanted.Right to left shunt and hypoxia was noted; therefore, an occluder was implanted successfully.Details are listed in the 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.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.A definitive cause for respiratory distress is also not confirmed in this case.Additional therapy/ non-surgical treatment was a result of case-specific circumstances as the patient was treated using an amplatzer asd occluder.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: 10422537
• MDR Text Key: 203459953
• Report Number: 2024168-2020-06878
• 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: company representative,health
• 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: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR