MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CX0202
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: zhang k, xia jc, gao hl, gao bl, wang yf, li zs, li tx, wang zl.Case report: double micro-guidewire technique for emergent rescue of proximal stent collapse during recanalization of nonacute occlusion of vertebral artery.Front neurol.2021 sep 3;12:671158.Doi: 10.3389/fneur.2021.671158.Pmid: 34539544; pmcid: pmc8446545.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone is not available / 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.The enterprise vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E., without subsequent coil embolization of the aneurysm.This stent was used off-label for the treatment of a v4 segment occlusion of the right vertebral artery.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 or Problem Description
This complaint is from a literature source.The citation is as follows: zhang k, xia jc, gao hl, gao bl, wang yf, li zs, li tx, wang zl.Case report: double micro-guidewire technique for emergent rescue of proximal stent collapse during recanalization of nonacute occlusion of vertebral artery.Front neurol.2021 sep 3;12:671158.Doi: 10.3389/fneur.2021.671158.Pmid: 34539544; pmcid: pmc8446545.Objective and methods: the article reports a case with v4 segment occlusion of the right vertebral artery treated with endovascular stent angioplasty.Lot number is not available, but the suspected cerenovus device possibly associated with reported event: 4.5mm x 28mm enterprise stent.Other cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: 2.0 × 13 mm gateway balloon (stryker), 300-cm traxcess micro-guidewire (0.014 inch, medtronic), echelon 10 microcatheter (medtronic).Adverse event(s) and provided interventions: a male patient in his 50s underwent endovascular stent angioplasty of a v4 segment occlusion with a 4.5mm x 28mm enterprise stent.The enterprise stent deployed at the occlusion segment was collapsed at the proximal end after withdrawal of the delivery system.Immediate rescuing measures were taken by navigating a micro-guidewire through the lateral stent mesh at the proximal end into the stent lumen followed by advancing a second micro-guidewire right through the reopened proximal stent end into the stent lumen for deployment of a supporting balloon-expandable apollo stent to prevent stent collapse.After stenting, both stents were well-patent with favorable forward flow.Follow-up digital subtraction angiography 6 months later demonstrated patent stents and unobstructed blood flow.
Event or Problem Description
This complaint is from a literature source.The citation is as follows: zhang k, xia jc, gao hl, gao bl, wang yf, li zs, li tx, wang zl.Case report: double micro-guidewire technique for emergent rescue of proximal stent collapse during recanalization of nonacute occlusion of vertebral artery.Front neurol.2021 sep 3;12:671158.Doi: 10.3389/fneur.2021.671158.Pmid: 34539544; pmcid: pmc8446545.Objective and methods: the article reports a case with v4 segment occlusion of the right vertebral artery treated with endovascular stent angioplasty.Lot number is not available, but the suspected cerenovus device possibly associated with reported event: 4.5mm x 28mm enterprise stent.Other cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: 2.0 × 13 mm gateway balloon (stryker), 300-cm traxcess micro-guidewire (0.014 inch, medtronic), echelon 10 microcatheter (medtronic).Adverse event(s) and provided interventions: a male patient in his 50s underwent endovascular stent angioplasty of a v4 segment occlusion with a 4.5mm x 28mm enterprise stent.The enterprise stent deployed at the occlusion segment was collapsed at the proximal end after withdrawal of the delivery system.Immediate rescuing measures were taken by navigating a micro-guidewire through the lateral stent mesh at the proximal end into the stent lumen followed by advancing a second micro-guidewire right through the reopened proximal stent end into the stent lumen for deployment of a supporting balloon-expandable apollo stent to prevent stent collapse.After stenting, both stents were well-patent with favorable forward flow.Follow-up digital subtraction angiography 6 months later demonstrated patent stents and unobstructed blood flow.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: zhang k, xia jc, gao hl, gao bl, wang yf, li zs, li tx, wang zl.Case report: double micro-guidewire technique for emergent rescue of proximal stent collapse during recanalization of nonacute occlusion of vertebral artery.Front neurol.2021 sep 3;12:671158.Doi: 10.3389/fneur.2021.671158.Pmid: 34539544; pmcid: pmc8446545.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone is not available / 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.The enterprise vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E., without subsequent coil embolization of the aneurysm.This stent was used off-label for the treatment of a v4 segment occlusion of the right vertebral artery.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to add the non-cerenovus devices that were also used in this study: 2.0 × 13 mm gateway balloon (stryker), 300-cm traxcess micro-guidewire (0.014 inch, medtronic), echelon 10 microcatheter (medtronic) updated sections: b.4, g.3, g.6, h.2, h.10, and concomitant products.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.

• Brand Name: EU ENT4.5MMD 28MML WNO DSTL TP
• Common Device Name: 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 ; 949789-8687
• MDR Report Key: 13012344
• Report Number: 3008114965-2021-00678
• Device Sequence Number: 17374954
• Product Code: NJE
• UDI-Device Identifier: 10878528008894
• UDI-Public: 10878528008894
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 641CX0202
• Device Catalogue Number: ENC452800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0 × 13 MM GATEWAY BALLOON (STRYKER); 300CM TRAXCESS MICROGUIDEWIRE (MICROVENTION); ECHELON 10 MICROCATHETER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male