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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0302
Device Problem Failure to Advance (2524)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001); Heart Failure (2206)
Event Date 04/09/2019
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the patient death. It was reported this was a mitraclip procedure to treat grade 4, functional mitral regurgitation (mr). Resistance was felt, with the anatomy, while advancing the steerable guide catheter (sgc) after advancing approximately 20-30cm. A venous rupture was noted, and the procedure was aborted. No clips were implanted. Mr remained at 4. The patient was sent to surgery for treatment of the perforation. The perforation was repaired and bleeding stopped. The patient was taken to the intensive care unit for recovery; however, due to cardiac failure, the patient died. Per the physician, the sgc caused the damage to the venous vessel and bleeding. Due to treatment with a coagulant for the bleeding, it was suspected that stent thrombosis occurred and may have caused the cardiac failure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8566278
MDR Text Key143599963
Report Number2024168-2019-03423
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/05/2020
Device Catalogue NumberSGC0302
Device Lot Number90104U203
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 Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
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: 04/30/2019 Patient Sequence Number: 1
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