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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR ALLIGATOR RETRIEVAL CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR ALLIGATOR RETRIEVAL CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hematoma (1884); Thromboembolism (2654)
Event Date 10/29/2019
Event Type  Death  
Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Abdalkader m, et al. J neurointervent surg 2020;12:505¿511. Doi:10. 1136/neurintsurg-2019-015278 ¿coil migration during or after endo vascular coiling of cerebral aneurysms¿ mohamad abdalkader , michel piotin , michael chen, santiago ortega-gutierrez, edgar samaniego, alain weill, alexander m norbash, thanh n nguyen medtronic received the following information through literature review: there were 18 /6071 cases of coil migration (no allegation of manufacture/ unknown coils). In 2 of the 18 events, an alligator retrieval device was used and thromboembilzation occurred. In 1 of these 2 a death was reported. In another event where the alligator device was used, the patient was reported to have suffered a hemorrhage and the alligator was unable to retrieve the coils. The alligator device was used in three cases but succeeded in only one of them. Patients were 15 men and three women. The mean age was 56. 4±14. 3 years. Endovascular retrieval devises included merci retrieval system (concentric medical inc, (b)(4), usa), snaring (amplatz gooseneck microsnare microvena corp, (b)(4), usa), alligator retrieval device (medtronic neurovascular, (b)(4), usa), and stent retriever.

 
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Brand NameALLIGATOR RETRIEVAL
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10102020
MDR Text Key193012743
Report Number2029214-2020-00508
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 05/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received05/15/2020
Was Device Evaluated By Manufacturer? No
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: 05/29/2020 Patient Sequence Number: 1
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