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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDING CATHETER VALVE REPAIR Back to Search Results
Catalog Number UNK SGC03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Perforation (2511)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative
This will be filed as a serious injury summary report per fda exemption approval number - e2015009. The device was not returned for analysis. A review of the lot history record could not be performed due to unknown lot information. Based on the limited information reviewed, a cause for the reported atrial perforation events could not be determined. The reported patient effect of atrial perforation, as listed in the mitraclip instructions for use (ifu), is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 32 atrial septal defect requiring intervention events which is considered a 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. Patients¿ mean age 73 years, ranging from 30 - 90 years. 72% patients were male, 28% patients were female. 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 GUIDING 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 Key11015281
MDR Text Key222089424
Report Number2024168-2020-10542
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
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: 12/15/2020 Patient Sequence Number: 1
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