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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number UNK SGC01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
Date of event: date estimated. 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. Literature titled, hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair.
 
Event Description
This is filed to report atrial perforation. It was reported through a research article that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3+. One clip was successfully implanted, reducing mr to a grade of 1+. After the steerable guide catheter (sgc) was removed, a right to left shunt was observed. The patients blood pressure then started to decrease; therefore, the physician decided to implant a closure device. The right to left shunt was treated and the patient blood pressure returned to normal. Details are listed in the article, titled ¿hemodynamic patterns of residual interatrial communication after transcatheter mitraclip repair. ¿ no additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE 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 Key11170870
MDR Text Key226822982
Report Number2024168-2021-00446
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK 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 Received02/10/2021
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: 01/14/2021 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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