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 Insufficient Information (4580)

Event Date 10/29/2021

Event Type  Death  

Event Description

This complaint is from a literature source.The citation is as follows: yu y, yan l, lou y, cui r, kang k, jiang l, mo d, gao f, wang y, lou x, miao z, ma n.Multiple predictors of in-stent restenosis after stent implantation in symptomatic intracranial atherosclerotic stenosis.J neurosurg.2021 oct 29:1-10.Doi: 10.3171/2021.6.Jns211201.Epub ahead of print.Pmid: 34715652.Objective and methods: this study aimed to identify predictors of intracranial in-stent restenosis (isr) after stent placement in symptomatic intracranial atherosclerotic stenosis (icas).The authors retrospectively collected data from consecutive patients who suffered from symptomatic icas and underwent successful stent placement in beijing tiantan hospital.Eligible patients were classified into ¿isr,¿ ¿indeterminate isr,¿ or ¿no-isr¿ groups by follow-up digital subtraction angiography or ct angiography.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: n/a.Non-cerenovus devices that were also used in this study: transcend 0.014-inch microwire, gateway balloon, neuroform ez stent, wingspan stent, apollo balloon-mounted stent.Adverse event(s) and provided interventions: there were 8 cases of in-stent restenosis (isr) associated with the enterprise stent.Isr was defined as > 50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and > 20% absolute luminal loss.Complications within 30 days were recorded including hyperperfusion syndrome, perforator stroke, and acute cerebral thrombosis.There were a total of 9 cases of hyperperfusion syndrome (2 isr, 2 indeterminate isr, and 5 no isr), 13 perforator strokes (2 isr, 7 indeterminate isr, and 4 no isr), and 3 acute cerebral thrombosis (0 isr, 2 indeterminate isr, and 1 no isr).There were a total of 97 recurrent strokes (42 isr, 35 indeterminate isr, and 20 no isr) and 13 deaths (1 isr, 8 indeterminate isr, and 4 no isr).Median time to recurrent stroke was 13.5 months - 18.0 months.There is insufficient information within the text of this article to identify which devices (s) (cerenovus or non-cerenovus) are associated with the reported complications.Exact quantities cannot be determined accurately as the article does not provide adequate information.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: yu y, yan l, lou y, cui r, kang k, jiang l, mo d, gao f, wang y, lou x, miao z, ma n.Multiple predictors of in-stent restenosis after stent implantation in symptomatic intracranial atherosclerotic stenosis.J neurosurg.2021 oct 29:1-10.Doi: 10.3171/2021.6.Jns211201.Epub ahead of print.Pmid: 34715652.Date of death: the date of death is not known / documented in the article.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.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.The stents were used off-label for symptomatic intracranial atherosclerotic stenosis.With the information provided, it is not possible to determine the root cause of the events.However, there are patient, procedural, and pharmacological factors that may have contributed.There is no indication that the device (s) malfunctioned or that the events were related to the device design or manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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: 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 ; 949789-868
• MDR Report Key: 12941484
• MDR Text Key: 281825695
• Report Number: 3008114965-2021-00633
• 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: Physician
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/26/2021
• 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: APOLLO BALLOON-MOUNTED STENT; GATEWAY BALLOON; NEUROFORM EZ STENT; TRANSCEND 0.014-INCH MICROWIRE; WINGSPAN STENT
• Patient Outcome(s): Death