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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

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MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER Back to Search Results
Catalog Number FRS21452299
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Code Available (3191)
Event Date 04/30/2017
Event Type  Death  
Manufacturer Narrative
Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.This information was not provided in the reported event or available at the time of report submission.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008114965-2020-00194, 3008114965-2020-00195, 3008114965-2020-00196, 3008114965-2020-00197.Are related to the same incident.
 
Event Description
This complaint is from a literature source.As reported in the literature publication entitled, ¿mechanical thrombectomy for ischaemic stroke: the first uk case series¿.4 patients with acute ischemic stroke (basilar artery occlusion) who underwent endovascular thrombectomy died within 90 days after mechanical thrombectomy.The purpose of this study is to investigate the parameters associated with 90-day mortality in patients with bao after mechanical thrombectomy.117 consecutive bao (basilar artery occlusion) patients included in the endovascular treatment in ischemic stroke prospective clinical registry of consecutive acute ischemic stroke patients treated with met (mechanical thrombectomy) (60 patients treated with a stent retriever as first-line technique) between march 2010 and april 2017 were analyzed.
 
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Brand Name
REVIVE SE 4.5MM OUS
Type of Device
EMBOLECTOMY CATHETER
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle neuchatel CH-24 00
SZ  CH-2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. (FREMONT)
47709 fremont blvd
fremont CA 94538
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key10090535
MDR Text Key192138111
Report Number3008114965-2020-00198
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberFRS21452299
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2020
Initial Date FDA Received05/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
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