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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA

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MICRO THERAPEUTICS, INC. DBA EV3 CATHERA Back to Search Results
Model Number FG15150-0615-1S
Device Problem Physical Resistance/Sticking (4012)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889)
Event Date 07/23/2020
Event Type  Death  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that two pipeline devices became stuck at the hub of the microcatheter. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the distal internal carotid artery with a max diameter of 4mm and a 5mm neck diameter. It was noted the patient's and vessel tortuosity was moderate. It was reported that the pipeline (pli-10) became stuck/locked up at the hub of the catheter during re-sheathing. A continuous flush had been administered, the physician released the slack in an attempt to resolve the issue, but the device was eventually removed. A second pipeline (pli-20) was prepared and experienced the same issue as the first pipeline. It was stated the patient's anatomy provided difficult access, and the system dropped back when deploying because the sofia was not supportive enough. There was no damage observed to the pipeline devices or microcatheter. Ancillary devices include a 5fr sofia, phenom 27. Additional information received reported devices were used for retrieval of pipeline into loop sheath for secondary deployment which is not indicated in the instructions for use (ifu). It was reported that after the pipeline jammed it detached in the proximal end of the microcatheter while attempting to recapture the device. This issue occurred twice, with both pipelines deploying in the microcatheter. The procedure was completed with a third pipeline; the doctor successfully compensated for drop back by providing more forward tension on the guide catheter. They started deployment more distal and dropped back. The pushwire was not rotated or pulled back at any time during the procedure. It was later reported that the patient had a hemorrhagic stroke and the procedure. The cause of the stroke was currently unknown, but it was not believed to be related to the device issues reported.

 
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Brand NameCATHERA
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10378746
MDR Text Key202181322
Report Number2029214-2020-00782
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK151638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFG15150-0615-1S
Device Catalogue NumberFG15150-0615-1S
Device LOT NumberJA20-019
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/10/2020
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: 08/07/2020 Patient Sequence Number: 1
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