MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thromboembolism (2654)

Event Date 12/04/2012

Event Type  Injury  

Event Description

Literature reviewed "stent placement for complex middle cerebral artery aneurysms" zhou, y., yang, p.F., li, q., zhao, r., fang, y.B., xu, y., hong, b., zhao, w.Y., huang, q.H., & liu, j.M.(2014).Stent placement for complex middle cerebral artery aneurysms.Journal of stroke and cerebrovascular diseases : the official journal of national stroke association, 23 (6), 1447¿1456.Https://doi.Org/10.1016/j.Jstrokecerebrovasdis.2013.12.054 objective and methods: background: to evaluate the safety and effectiveness of stent placement for ruptured or unruptured middle cerebral artery (mca) aneurysms in a larger number.Methods: between october 2003 and december 2012, data for 70 patients with 72 complex mca aneurysms treated with stents at our institution were retrospectively collected and analyzed.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: n/a adverse event(s) and provided interventions: ¿intrastent thrombosis during the procedure - intra-artery administration of tirofiban was performed immediately, and a second stent was deployed for one of them because coil protrusion was thought to be responsible for the thrombosis.¿ ¿one aneurysm with an initial residual sac and 2 aneurysms with a remnant neck were recanalization, one of them was retreated with additional stent-assisted coiling, 9-month follow-up showed a total obliteration.¿ ¿one case of aneurysm rebleeding was noted immediately after the procedure on dyna ct, with increased hematoma.Craniotomy was subsequently performed.¿ ¿procedure-related complications included 1 inferior branch obliteration and 1 lenticulostriate artery area infarction.Both were managed conservatively.¿.

Manufacturer Narrative

(b)(4).Zhou, y., yang, p.F., li, q., zhao, r., fang, y.B., xu, y., hong, b., zhao, w.Y., huang, q.H., & liu, j.M.(2014).Stent placement for complex middle cerebral artery aneurysms.Journal of stroke and cerebrovascular diseases : the official journal of national stroke association, 23 (6), 1447¿1456.Https://doi.Org/10.1016/j.Jstrokecerebrovasdis.2013.12.054 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.Since the product has not been returned, no corrective action is warranted at this time.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00096.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.

• Brand Name: UNKENTERPRISE2
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12610708
• MDR Text Key: 282040580
• Report Number: 1226348-2021-00095
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention