MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 08/07/2012

Event Type  Injury  

Event Description

This complaint is from a literature source.The citation is as follows: vajda z, güthe t, perez ma, kurre w, schmid e, bäzner h, henkes h.Prevention of intracranial in-stent restenoses: predilatation with a drug eluting balloon, followed by the deployment of a self-expanding stent.Cardiovasc intervent radiol.2013 apr;36(2):346-52.Doi: 10.1007/s00270-012-0450-9.Epub 2012 aug 7.Pmid: 22869043; pmcid: pmc3595472.Objective and methods: in this study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (deb) followed by the implantation of a self-expanding stent (enterprise) were evaluated for the treatment of intracranial atherosclerotic disease (icad) lesions, fifty-two patients underwent stenting of high-grade icad lesions between february 2010 and november 2011 in a single center.Lot, model and catalog numbers are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent concomitant cerenovus devices that were also used in this study: rapidtransit microcatheter, prowler select plus microcatheter concomitant non-cerenovus devices that were also used in this study: silverspeed-14 microwire (covidien/ev3), traxcess14 microwire (terumo), ryujin plus balloon (terumo), sequent please drug eluting balloon (b.Braun), dior drug eluting balloon (eurocor).Adverse event(s) and provided interventions: a (b)(6) male patient experienced a new infarction of the dorsolateral medulla, permanent deficit.A (b)(6) male patient experienced a new infarction in the pons, permanent deficit.A (b)(6) male patient experienced reinfarction in the pons, permanent deficit, exitus.A (b)(6) female patient experienced two small lacunae in the anterior cerebral artery (aca) area.A (b)(6) female patient experienced basal ganglia ischemia two days later, clopidogrel resistance.An (b)(6) male patient experienced new subcortical diffusion weighted imaging (dwi) lesion bilateral.A (b)(6) female patient experienced small dwi lesions in pons.A (b)(6) male patient experienced small dwi lesions in cerebellum.A (b)(6) female experienced a subarachnoid hemorrhage (sah) around stented internal carotid artery (ica) segment.A (b)(6) male patient experienced small dwi lesion in pons.A (b)(6) female patient experienced stent thrombus during the intervention, immediately recanalized, small petechiae in basal ganglia.There was one asymptomatic in-stent recurrent stenotic lesion developed in the m1 segment of a left middle cerebral artery (mca) 3 months after the angioplasty with a dior deb and implantation of an enterprise stent.

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The citation is as follows: vajda z, güthe t, perez ma, kurre w, schmid e, bäzner h, henkes h.Prevention of intracranial in-stent restenoses: predilatation with a drug eluting balloon, followed by the deployment of a self-expanding stent.Cardiovasc intervent radiol.2013 apr;36(2):346-52.Doi: 10.1007/s00270-012-0450-9.Epub 2012 aug 7.Pmid: 22869043; pmcid: pmc3595472.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter phone is not available.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.This information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.The article cannot be attached to due electronic file size.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13078922
• MDR Text Key: 288292338
• Report Number: 3008114965-2021-00771
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Treatment: DIOR DRUG ELUTING BALLOON (EUROCOR); PROWLER SELECT PLUS MICROCATHETER; RAPIDTRANSIT MICROCATHETER; RYUJIN PLUS BALLOON (TERUMO); SEQUENT PLEASE DRUG ELUTING BALLOON (B. BRAUN); SILVERSPEED-14 MICROWIRE (COVIDIEN/EV3); TRAXCESS14 MICROWIRE (TERUMO)
• Patient Outcome(s): Life Threatening