MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF403012

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

Patient Problem Aneurysm (1708)

Event Date 02/26/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following citation was reviewed: roh h, kim j, suh si, kwon th, yoon w.Is stent-assisted coil embolization for the treatment of ruptured blood blister-like aneurysms of the supraclinoid internal carotid artery effective? : an analysis of single institutional experience with pooled data.J korean neurosurg soc.2021 mar;64(2):217-228.Doi: 10.3340/jkns.2020.0174.Epub 2021 feb 26.Pmid: 33715324; pmcid: pmc7969050.Objective and methods: this study aimed to evaluate the efficacy and safety of stent-assisted coil embolization (sac) for the treatment of ruptured blood blister-like aneurysms (bbas) of the supraclinoid internal carotid artery (ica).A total of 8 patients with ruptured bbas who were treated between january 2008 and december 2017 were enrolled in the study.Lot numbers are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise 2 vascular reconstruction device (vrd) concomitant cerenovus devices that were also used in this study: prowler select plus microcatheter.Concomitant non-cerenovus devices that were also used in this study: 6 or 7-f shuttle guiding catheter; neuroform ez stent (stryker).Adverse event(s) and provided interventions: case #3: a (b)(6) female patient underwent sac of a ruptured ophthalmic (c6) bba with a single 4mm x 23mm enterprise 2 stent and three coils (unspecified).A raymond classification of 2 was achieved.No procedural complications were observed.In a follow-up digital subtraction angiography (dsa) performed 6 months (180 days) after the initial endovascular treatment, asymptomatic recurrence of the treated bba was observed.Two intracranial stents (lvis blue 3.5×17 mm; microvention) were deployed within the previously inserted stent.Gradual improvement and, eventually, complete angiographic resolution of the recurred aneurysm was observed in serial dsa studies.Case #6: a (b)(6) female patient with a history of thyroid cancer underwent sac of a ruptured ophthalmic (c6) bba with a single 4mm x 30mm enterprise 2 stent and three coils (unspecified).In a follow-up digital subtraction angiography (dsa) performed 150 days after the initial endovascular treatment, asymptomatic recurrence of the treated bba was observed.Two intracranial stents (lvis blue 3.5×17 mm; microvention) were deployed within the previously inserted stent.

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The following citation was reviewed: roh h, kim j, suh si, kwon th, yoon w.Is stent-assisted coil embolization for the treatment of ruptured blood blister-like aneurysms of the supraclinoid internal carotid artery effective? : an analysis of single institutional experience with pooled data.J korean neurosurg soc.2021 mar;64(2):217-228.Doi: 10.3340/jkns.2020.0174.Epub 2021 feb 26.Pmid: 33715324; pmcid: pmc7969050.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 contact information 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ENTERPRISE2 4MMX30MM
• 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: 13515715
• MDR Text Key: 290158016
• Report Number: 3008114965-2022-00101
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075370
• UDI-Public: 10886704075370
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/11/2022

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 Model Number: ENF403012
• Device Catalogue Number: ENF403012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/11/2022
• 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: 6 OR 7-F SHUTTLE GUIDING CATHETER; NEUROFORM EZ STENT (STRYKER); PROWLER SELECT PLUS MICROCATHETER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female