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

Catalog Number SGC0302

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Atrial Perforation (2511)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information."transcatheter closure of atrial septal defect was required after transcatheter mitral valve repair: a case report¿.

Event Description

This is filed to report the atrial septal defect (asd).It was reported that after the mitraclip procedure was performed an atrial septal defect (asd) was treated with a closure device.Details are listed in the attached article, titled "transcatheter closure of atrial septal defect was required after transcatheter mitral valve repair: a case report.¿ please see article for additional information.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: this event was previously filed under mfr 2024168-2018-05761.This event is a duplicate of that event.Please see above report for complete details.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Since this medwatch was previously filed, it must remain reportable; however, this event was previously reported under mft # 2024168-2018-05761.This event is a duplicate of that event.

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Article attachment: "transcatheter closure of atrial septal defect was required after transcatheter mitral valve repair: a case report¿na - attachment: [cn-011807 article.Pdf].

• 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: 9282836
• MDR Text Key: 165433567
• Report Number: 2024168-2019-13266
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention