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 Problem Perforation (2001)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

The udi number is not known as the part and lot number were not provided. The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional clip delivery system device referenced is filed under separate medwatch report number.

Event Description

This is filed to report atrial perforation and prolonged hospitalization. It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr). On (b)(6) 2020, a steerable guide catheter (sgc) was advanced to the mitral valve, and one clip was successfully deployed, reducing mr. However, on (b)(6) 2021, the patient was transferred to another hospital with heart failure due to mean pressure gradient of 8mmhg and a bi directional shunt was discovered in the atrial septal defect (asd). The patient will remain hospitalized and is pending surgery. The clip remains stable on both leaflets, and mr is 2. 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: 11688789
• MDR Text Key: 246657999
• Report Number: 2024168-2021-03272
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK SGC03
• 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: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 04/19/2021 Patient Sequence Number: 1