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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 Stroke/CVA (1770); Death (1802)
Event Date 01/31/2013
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 no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008114965-2020-00200, 3008114965-2020-00201, 3008114965-2020-00202, 3008114965-2020-00203, and 3008114965-2020-00206 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.¿ 1 patient with acute ischemic stroke who underwent endovascular treatment with thrombectomy died due to later complications of the persistent severe stroke.Purpose: endovascular treatments have the potential to accelerate reperfusion in acute ischaemic stroke with large vessel occlusion.Results of the first 106 endovascular treatments (evt) in the uk were presented in the article.Methods: from december 2009 to january 2013 106 patients (mean age 64 years, median baseline nihss 18) were treated with evt (thrombectomy ± iat 83%, iat (intra-arterial thrombolysis) alone 13%, neither 4%).
 
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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 Key10092577
MDR Text Key192200297
Report Number3008114965-2020-00205
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
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 05/05/2020
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 05/05/2020
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 Age64 YR
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