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

Catalog Number SGC0302

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

Patient Problem Perforation (2001)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the atrial perforation (atrial septal defect). It was reported the initial mitraclip procedure was performed on (b)(6) 2019. Two clips were implanted, reducing mixed mitral regurgitation (mr) from 4 to1. At the end of this procedure, the shunt was in the left to right direction. On (b)(6) 2021, the patient was hospitalized due to gastrointestinal bleeding, anemia, pleural effusion, congestive heart failure and exacerbation of tricuspid regurgitation (tr). The implanted clip was not related with gastrointestinal bleeding, anemia, pleural effusion, congestive heart failure and exacerbation of tr). Due to the worsening tr, the shunt was now in the right to left direction. On (b)(6) 2021, echocardiogram was performed, mr increased to 3-4. Per the physician, the mr exacerbation is not related to the implanted clips. The mr exacerbated due to worsening tr, by pleural effusion and increasing right heart load. The clips were confirmed to be secure on both leaflets and there was no injury related to the implanted clips. The physician wanted to reduce mr before closing the shunt, therefore a second mitraclip procedure was performed on (b)(6) 2021. The atrial septal defect hole that was punctured during initial procedure was used again during the second mitra clip procedure. One clip was placed on a2/p2 reducing mr to 1. A balloon was implanted in the atrial septum as temporary treatment for the shunt. The patient was transferred to another hospital and a closure device was implanted on (b)(6) 2021, resolving the shunt. No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11543591
• MDR Text Key: 241699410
• Report Number: 2024168-2021-02220
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/05/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81204U214
• 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: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: 03/22/2021 Patient Sequence Number: 1