MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 14MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF2505

Device Problem Migration (4003)

Patient Problem Restenosis (4576)

Event Date 07/19/2011

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The citation is as follows: vajda z, schmid e, güthe t, klötzsch c, lindner a, niehaus l, sperber w, peters j, arnold g, bäzner h, henkes h.The modified bose method for the endovascular treatment of intracranial atherosclerotic arterial stenoses using the enterprise stent.Neurosurgery.2012 jan;70(1):91-101; discussion 101.Doi: 10.1227/neu.0b013e31822dff0f.Pmid: 21778921.The lot numbers are not available / not reported.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.

Event Description

This complaint is from a literature source.The citation is as follows: vajda z, schmid e, güthe t, klötzsch c, lindner a, niehaus l, sperber w, peters j, arnold g, bäzner h, henkes h.The modified bose method for the endovascular treatment of intracranial atherosclerotic arterial stenoses using the enterprise stent.Neurosurgery.2012 jan;70(1):91-101; discussion 101.Doi: 10.1227/neu.0b013e31822dff0f.Pmid: 21778921.Objective and methods: the purpose of this study was to evaluate the procedural safety and stenosis recurrence rate by the use of a stent with reduced radial force (enterprise).A total of 189 patients (median age, 68 years; age range, 41-88 years; male-to-female ratio, 132/57) with 209 intracranial atherosclerotic lesions were enrolled and treated in the registry.Lot, model and/or catalog number 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: n/a adverse event(s) and provided interventions: (1) delayed proximal migration of a 14-mm enterprise stent was observed in 1 patient treated for a symptomatic left middle cerebral artery (mca) stenosis after failed indirect extracranial-intracranial bypass surgery.An approximately 5-mm proximal migration of the stent was observed at the 12-week angiographic follow-up, together with a recurrent stenosis at the site of the original lesion that remained unscaffolded because of the migration of the stent (1) subarachnoid hemorrhage on the third postinterventional day, hunt and hess grade i, no treatment was initiated, the symptoms resolved without sequelae (9) symptomatic ischemic lesions in the territory of the stented artery with resolution of the symptoms within 30 days (1) temporary stent thrombosis successfully treated with selective lysis therapy with complete resolution of the symptoms within 30 days (1) direct carotid-cavernous sinus fistula (ccf), requiring further endovascular treatment (2) asymptomatic dissection of the stented segment (43) the primary end point of recurrent stenosis, defined as an in-stent stenotic lesion of more than 50% on the follow-up dsa series, was reached by 43 of 174 lesions after an average follow-up of 4.2 months.Four of these lesions were symptomatic with transient ischemic attacks (tias) or stroke in the dependent vascular territory.Thus, the overall rate of recurrent ischemia or stroke in the territory of the stented vessel in lesions with at least one follow-up examination was 4/174 during the follow-up period.

• Brand Name: EU ENT4.5MMD 14MML WNO DSTL TP
• 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
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13077628
• MDR Text Key: 284867443
• Report Number: 3008114965-2021-00765
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009457
• UDI-Public: 10878528009457
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 641CF2505
• Device Catalogue Number: ENC451400
• 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: PROWLER SELECT PLUS MICROCATHETER; RAPIDTRANSIT MICROCATHETER