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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 SGC03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
The devices were not returned for analysis. A review of the lot history record could not be performed as this incident was based on tvt registry data, and no device/lot information was provided. Based on available information, causes for the reported atrial perforation could not be determined. Furthermore, the reported patient effect of atrial perforation is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures. The reported unexpected medical interventions were the result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design, or labeling. Date of event, implant/explant date: dates estimated.
 
Event Description
It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 3 perforation (atrial septal defect) requiring intervention adverse events which are considered serious injury. The relationship of the adverse events to the mitraclip device could not be determined based on the limited data received from the registry. Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009. 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 Key13004511
MDR Text Key287412731
Report Number2024168-2021-11568
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
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: 12/14/2021 Patient Sequence Number: 1
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