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

Catalog Number UNK SGC01

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

Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Perforation (2001)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Date estimated. The udi number is not known as the part and lot number were not provided. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Literature attachment :haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.

Event Description

This is being filed to report the atrial septal defect (asd) and treatment. It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr). The mitraclip was successfully implanted. Following withdrawal of the steerable guide catheter (sgc), the patient immediately developed bronchospasm and pulmonary hypertension and a bidirectional shunt was detected. The issue was resolved through percutaneous closure with either an amplatzer or figulla occluder. No additional information was provided. Details are listed in the attached article: "haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy".

• 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: 11724748
• MDR Text Key: 247282653
• Report Number: 2024168-2021-03513
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK SGC01
• 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: 05/27/2021
• 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: 04/26/2021 Patient Sequence Number: 1