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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 Pulmonary Embolism (1498); Thrombosis (2100); Foreign Body In Patient (2687)
Event Date 09/24/2020
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. The mitraclip referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report pulmonary embolism and foreign body. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. Prior to the procedure, it was noted that the patient had a flail of the mitral valve. After the steerable guide catheter (sgc) was inserted, a blood clot was observed at the tip of the dilator. The sgc was removed and aspiration was performed to remove the blood clot. It was noted that a portion of the blood clot was removed, but the other portion of the blood clot had migrated into the lungs. The blood clot then became lodged in the auricle appendage. The sgc and clip were then inserted and both leaflets were successfully grasped; therefore, the clip was attempted to be implanted. While removing the lock line, the lock line became stuck and was unable to be removed. At this time, it was noted that a knot had occurred on the lock line. In an attempt to retrieve the lock line, the physician tried breaking the lock lever; however, this was unsuccessful. The physician then decided to pull on the lock line until it broke. The physician stated that roughly 8 to 10 inches remained in the anatomy. It was noted that the clip was stable on the leaflets, but as a precaution, the physician decided to implant an additional clip to make sure the clip was completely stable. Mr reduced to a grade of <1. For treatment of the blood clot, the patient was put on blood thinners. 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 Key10793209
MDR Text Key214820073
Report Number2024168-2020-09254
Device Sequence Number1
Product Code DRA
UDI-Device Identifier08717648216824
UDI-Public08717648216824
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 12/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/12/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00213U159
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 Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2020
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: 11/05/2020 Patient Sequence Number: 1
Treatment
DILATOR
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