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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 Problem Atrial Perforation (2511)
Event Date 03/15/2012
Event Type  Injury  
Manufacturer Narrative
Date of event: date estimated (udi#): in the absence of a reported part number, the udi cannot be calculated. The devices are not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional mitraclip devices referenced in b5 are filed under a separate medwatch report number. Literature attachment. Article title ¿prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the mitraclip system¿na.
 
Event Description
This is filed to report atrial perforation it was reported through a research article that 30 patients with mitral regurgitation underwent a mitraclip procedure and had an atrial septal defect after the procedure was completed. Within 12 months of the procedure, 8 patients had an atrial septal defect that was still present and recurrent mitral regurgitation. Details are listed in the attached article, titled ¿prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the mitraclip system. ¿ 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 Key11193532
MDR Text Key227507762
Report Number2024168-2021-00557
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
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 Received01/25/2021
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: 01/19/2021 Patient Sequence Number: 1
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