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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
Model Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Thrombosis (2100)
Event Date 05/14/2020
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional two mitraclips devices are filed under a separate medwatch report number.
 
Event Description
This is filed to report thrombus. It was reported that on (b)(6) 2020, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4. Prior to procedure, it was noted that the patient had severe barlow¿s disease and a posterior leaflet flail. Three clips were successfully implanted, reducing mr to grade of 1. On a later date, echocardiography was performed and showed mr had increased to a grade of 4. On (b)(6) 2020, a second procedure as performed. At this time, it was confirmed that the first two implanted clip (91206u145, 91206u146) had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda). In an attempt to implant a fourth clip, a steerable guide catheter (sgc) (90723u254) was inserted, but after crossing the septum through the original transseptal puncture, a large thrombus was observed in the right atrium (ra). It was suspected that the thrombus originated in the right femoral vein. After an extensive discussion, the physician decided to proceed with the procedure. However, at this time, the thrombus was no longer visible via transesophageal echocardiogram (tee). It was presumed that the during the discussion, the thrombus had migrated into the right ventricle (rv) or the lungs; however, tee of the rv and pulmonary tree were unable to determine the position of the thrombus. A fourth clip was successfully implanted to stabilize the two slda clips. Mr reduce to a grade of < 1. There was no clinically significant delay in the procedure. 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 Key10111138
MDR Text Key193419720
Report Number2024168-2020-04669
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/23/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number90723U254
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 Received06/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2019
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: 06/02/2020 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP (X3)
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