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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 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.
 
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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 Key11543591
MDR Text Key241699410
Report Number2024168-2021-02220
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
Number of Events Reported1
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 Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/05/2019
Device Catalogue NumberSGC0302
Device Lot Number81204U214
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 Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2018
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
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