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 Thromboembolism (2654)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: zang y, wang c, zhang y, ding x, wang y, wang x, wang z.Long-term follow-up study of 35 cases after endovascular treatment for vertebrobasilar dissecting aneurysms.Clin neurol neurosurg.2015 oct;137:121-31.Doi: 10.1016/j.Clineuro.2015.07.004.Epub 2015 jul 7.Pmid: 26196477.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source and the following citation was reviewed: zang y, wang c, zhang y, ding x, wang y, wang x, wang z.Long-term follow-up study of 35 cases after endovascular treatment for vertebrobasilar dissecting aneurysms.Clin neurol neurosurg.2015 oct;137:121-31.Doi: 10.1016/j.Clineuro.2015.07.004.Epub 2015 jul 7.Pmid: 26196477.Objective and methods: authors report experiences using endovascular treatment for vbda patients to assess the efficacy and safety of several vbda treatment strategies.Assisted by intra-arterial digital subtraction angiography, 35 patients in our hospital were treated using various vbda treatment strategies, including stent-assisted coil embolization (20 patients), placement of single or multiple overlapping stents (5 patients) or coil embolization combined with proximal coil trapping of the dissected segment of the parent artery (ce + pt; 10 patients).The articles notes deaths and complications as not related to device (s) but due to the complexity of the presenting conditions of ruptured vbda with subarachnoid hemorrhage (sah).Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Other cerenovus devices that were also used in this study: a 6f or 7f envoy guiding catheter, prowler plus microcatheter non-cerenovus devices that were also used in this study: traxcess guidewire (microventioninc), neuroform stent (neuroform boston scientific).Coils were utilized but the article does not identify manufacturer of coils.Article also does not identify which manufacturer devices are associated with the adverse events.Adverse event(s) and provided interventions: patient no 18 (b)(6) female with presenting sah had intraoperative thrombi in the parent artery and treated with urokinase (failed) and tirofiban (successful) resulting in complete patency.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle nechatel CH240 0; SZ CH2400
• MDR Report Key: 12597974
• MDR Text Key: 282492180
• Report Number: 1226348-2021-00088
• 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,health professional,l
• Type of Report: Initial
• Report Date: 09/12/2021

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
• Initial Date Manufacturer Received: 09/12/2021
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A 6F OR 7F ENVOY GUIDING CATHETER; NEUROFORM STENT (NEUROFORM BOSTON SCIENTIFIC); PROWLER PLUS MICROCATHETER; TRAXCESS GUIDEWIRE (MICROVENTIONINC)
• Patient Outcome(s): Other
• Patient Age: 49 YR