MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

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

Patient Problems Fistula (1862); Atrial Perforation (2511)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned. It has not yet been received. A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed due to an atrial septal defect and arteriovenous fistula. It was reported that the patient presented with degenerative mitral regurgitation (mr) grade 3+, with a bi-leaflet prolapse (a3p3) and anterior leaflet flail. Two mitraclips were implanted without a device issue, reducing the mr to grade 1+. An atrial septal defect (asd) was treated with an asd closure device. Post-procedure, a groin arteriovenous fistula was noted. Imaging was performed and conservative treatment was provided with compressions. Prolonged hospitalization was required. The event resolved and the patient was discharged from the hospital on (b)(6) 2018. No additional information was provided regarding this issue.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8347565
• MDR Text Key: 136488905
• Report Number: 2024168-2019-01180
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/15/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80515U151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/18/2019 Patient Sequence Number: 1