MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GUIDE CATHETER; PERCUTANEOUS CATHETER

Catalog Number UNKENVOY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature article citation: "comparison of micro-clamping stent-retriever thrombectomy with conventional stent-retriever thrombectomy in intracranial large vessel embolism" reviewed.Liu, z.S., deng, g., zhou, l.J., sun, y., zhang, x.J., kuang, x.W., qin, y.L., wang, j.X., & shan, q.(2018).World neurosurgery , 116 , e662¿e669.Https://doi.Org/10.1016/j.Wneu.2018.05.066 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

Literature article "comparison of micro-clamping stent-retriever thrombectomy with conventional stent-retriever thrombectomy in intracranial large vessel embolism" reviewed.Liu, z.S., deng, g., zhou, l.J., sun, y., zhang, x.J., kuang, x.W., qin, y.L., wang, j.X., & shan, q.(2018).World neurosurgery , 116 , e662¿e669.Https://doi.Org/10.1016/j.Wneu.2018.05.066 objective and methods: to evaluate the effectiveness of microclamping stent-retriever thrombectomy (msrt) in patients with acute ischemic stroke with intracranial large vessel embolism (ilve), and compare it with that of conventional stent-retriever thrombectomy (csrt).We retrospectively evaluated 108 patients with ilva treated by msrt (n [ 52) or csrt (n [ 56) from the 2 participating institutions between january 2016 and november 2017.The rates of successful (modified thrombolysis in cerebral infarction [mtici] grade 2b or 3) and complete reperfusion (mtici grade 3), time from guide catheter placement to reperfusion, rates of first-pass success, and the number of passes for reperfusion were compared between the msrt and csrt groups.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: envoy catheter 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: 11 patients experienced subarachnoid hemorrhage post-operatively.

Manufacturer Narrative

(b)(4) under mrn 3008264254-2021-00039 is being retracted.The report was submitted in error.Retraction of initial report (b)(4) under mrn 3008264254-2021-00039.

• Brand Name: GUIDE CATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle nechatel CH240 0; SZ CH2400
• MDR Report Key: 12573825
• MDR Text Key: 282288259
• Report Number: 3008264254-2021-00039
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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: UNKENVOY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening