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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 Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Event Date 05/06/2020
Event Type  Death  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, a definitive cause for perforation that resulted in hypotension could not be determined in this complaint. The reported patient death was due to injury per the physician. The reported patient effects of death, hypotension and perforation are listed in the mitraclip system instructions for use (ifu) as known possible complication associated with mitraclip procedures. Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
This is filed to report during the procedure, iliac vein perforation and death occurred. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation with grade of 4. The steerable guide catheter (sgc) was advanced; however, while the sgc was being advanced the patient¿s blood pressure dropped. An investigation was performed to see what was causing the patient¿s blood pressure to decline. Medication was administered but was unsuccessful. The sgc was removed and fluoroscopy noted that the iliac vein had a perforation. A vascular surgeon was consulted, and the vascular surgeon implanted a covered stent to treat the perforation successfully. The procedure was aborted, and the patient was sent to intensive care unit (icu). After two hours the patient began to decline and died. Reportedly, the patient¿s death was due to the injury. 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 Key10079196
MDR Text Key191707503
Report Number2024168-2020-04453
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
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91015U149
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 Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2019
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: 05/21/2020 Patient Sequence Number: 1
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