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 Transient Ischemic Attack (2109)

Event Date 05/01/2016

Event Type  Injury  

Event Description

This complaint is from a literature source.The citation is as follows: zhao y, jin m, liu q, liu d, chen j, du b.[a long-term follow-up results of enterprise stent in treatment of severe symptomatic basilar artery atherosclerotic stenosis].Zhonghua nei ke za zhi.2016 may 1;55(5):372-6.Chinese.Doi: 10.3760/cma.J.Issn.0578-1426.2016.05.008.Pmid: 27143187.Objective and methods: the purpose of this study was to evaluate the safety and efficacy of enterprise stent in the treatment of severe symptomatic basilar artery atherosclerosis stenosis.All patients who underwent enterprise stent for the treatment of symptomatic basilar artery atherosclerotic stenosis in the single institution from nov.2011 to nov.2014 were enrolled in the study.A total of 35 cases were enrolled in the study with operation technical success rate of 100%.The main perioperative complication and mortality rate was 0.Lot, model and 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: n/a.Concomitant non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: (2) during follow-up period, 2 cases of transient ischemic attack (tia) related to the stented artery were observed.(1) one patient with in-stent restenosis suffered from transient cerebral ischemia and received another enterprise stenting successfully.

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The citation is as follows: zhao y, jin m, liu q, liu d, chen j, du b.[a long-term follow-up results of enterprise stent in treatment of severe symptomatic basilar artery atherosclerotic stenosis].Zhonghua nei ke za zhi.2016 may 1;55(5):372-6.Chinese.Doi: 10.3760/cma.J.Issn.0578-1426.2016.05.008.Pmid: 27143187.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.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.The article cannot be attached to due electronic file size.

Event Description

This complaint is from a literature source.The citation is as follows: zhao y, jin m, liu q, liu d, chen j, du b.[a long-term follow-up results of enterprise stent in treatment of severe symptomatic basilar artery atherosclerotic stenosis].Zhonghua nei ke za zhi.2016 may 1;55(5):372-6.Chinese.Doi: 10.3760/cma.J.Issn.0578-1426.2016.05.008.Pmid: 27143187.Objective and methods: the purpose of this study was to evaluate the safety and efficacy of enterprise stent in the treatment of severe symptomatic basilar artery atherosclerosis stenosis.All patients who underwent enterprise stent for the treatment of symptomatic basilar artery atherosclerotic stenosis in the single institution from nov.2011 to nov.2014 were enrolled in the study.A total of 35 cases were enrolled in the study with operation technical success rate of 100%.The main perioperative complication and mortality rate was 0.Lot, model and 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: n/a.Concomitant non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: (2) during follow-up period, 2 cases of transient ischemic attack (tia) related to the stented artery were observed.(1) one patient with in-stent restenosis suffered from transient cerebral ischemia and received another enterprise stenting successfully.

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The citation is as follows: zhao y, jin m, liu q, liu d, chen j, du b.[a long-term follow-up results of enterprise stent in treatment of severe symptomatic basilar artery atherosclerotic stenosis].Zhonghua nei ke za zhi.2016 may 1;55(5):372-6.Chinese.Doi: 10.3760/cma.J.Issn.0578-1426.2016.05.008.Pmid: 27143187.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.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.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: 13043019
• MDR Text Key: 285933353
• Report Number: 3008114965-2021-00751
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/20/2021

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 Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• 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