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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 Atrial Perforation (2511)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
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 available information, a cause for the reported atrial perforation could not be determined. The reported patient effect of atrial perforation is listed in the mitraclip system instructions for use and is a known possible complication associated with mitraclip procedures. The reported additional therapy/non-surgical treatment and hospitalization were results of case-specific circumstances, as further hospitalization and implantation of an asd closure device were needed to treat the atrial perforation. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is being filed to report the atrial septal defect requiring intervention. It was reported that this was a triclip procedure to treat tricuspid regurgitation (tr) with a grade of 4. The triclip delivery system (tcds) was advanced to the posterior/septal part of the valve however the leaflets were unable to be grasped due to the coaptation gap. The tcds was moved to the anterior/septal central portion of the valve. The leaflets were grasped however the tr was not reduced therefore the leaflets were ungrasped and the tcds removed. The procedure was aborted with the tr remaining at 4. An atrial septal defect (asd) was noted during the procedure, as a result from a mitraclip procedure on a previous date. The transesophageal echocardiography (tee) showed a bi-directional shunt therefore an attempt was made to use an amplatzer plug however was unsuccessful therefore the asd was treated with another device. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key10959583
MDR Text Key219914279
Report Number2024168-2020-10208
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSGC0302
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 Received11/16/2020
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: 12/07/2020 Patient Sequence Number: 1
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