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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); Perforation of Vessels (2135)
Event Date 03/09/2013
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 the 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: 3008114965-2020-00210, 3008114965-2020-00211, and 3008114965-2020-00212 are related to the same incident.
 
Event Description
This complaint is from a literature source.As reported in the literature publication entitled,¿ stent retrievers in acute ischemic stroke: complications and failures during the perioperative period.¿ 1 patient with ischemic stroke and large-vessel occlusion who underwent stent retriever¿assisted thrombectomy experienced an arterial perforation and died subsequently.Purpose: stent retriever¿assisted thrombectomy promotes high recanalization rates in acute ischemic stroke.Nevertheless, complications and failures occur in more than 10% of procedures; hence, there is a need for further investigation.Method: a total of 144 patients with ischemic stroke presenting with large-vessel occlusion were prospectively included.Patients were treated with stent retriever¿assisted thrombectomy_iv fibrinolysis.
 
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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 Key10143139
MDR Text Key194797702
Report Number3008114965-2020-00213
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 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue NumberFRS21452299
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2020
Initial Date FDA Received06/11/2020
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 Age69 YR
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