MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No (b)(4).(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 5715051.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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 Description

The healthcare professional reported that during the procedure targeting an intracranial arterial stenosis, the 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412 / 5715051) deployed and became detached in the concomitant microcatheter.The physician replaced the stent and completed the procedure.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 13 january 2021.This mdr will also report that the product was received by the product analysis lab on 13 january 2021.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.[additional event information]: the healthcare professional reported that during the procedure targeting a middle cerebral artery (mca) stenosis in the 52-year-old female patient, the 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412 / 5715051) deployed and became detached in the concomitant prowler select plus microcatheter (606s255x / 30447568).It was reported that adequate and continuous flush was maintained through the microcatheter.There was nothing unusual noted on the system prior to use.The device as used in accordance to the instructions for use (ifu).The physician replaced the stent, reintroduce the stent in the same prowler select plus microcatheter, delivery the stent to the target and released the stent to complete the procedure.There was a 20-minute procedure delay that was deemed clinically significant, however, the reason for the significance of the delay was not provided.There was no report of any patient adverse event or complication.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure targeting a middle cerebral artery (mca) stenosis in the 52-year-old female patient, the 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412 / 5715051) deployed and became detached in the concomitant prowler select plus microcatheter (606s255x / 30447568).It was reported that adequate and continuous flush was maintained through the microcatheter.There was nothing unusual noted on the system prior to use.The device as used in accordance with the instructions for use (ifu).The physician replaced the stent, reintroduce the stent in the same prowler select plus microcatheter, delivery the stent to the target and released the stent to complete the procedure.There was a 20-minute procedure delay that was deemed clinically significant, however, the reason for the significance of the delay was not provided.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 14mm enterprise® vascular reconstruction device was received contained in a pouch.Visual inspection was performed.It was noted that the stent was returned in detached state but was observed to be in good condition.The delivery wire and the introducer were inspected and were observed to be in normal good condition.Functional evaluation could not be performed as the stent component was already detached.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 5715051.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported that during the procedure, the 4.5mm x 14mm enterprise® vascular reconstruction device deployed and became detached in the concomitant prowler select plus microcatheter.The reported issue that the stent prematurely detached was confirmed based on the visual inspection; the stent component was received already detached.It could have become detached during procedure handling.The exact time when the detachment occurred and whether the premature detachment occurred while it was in the microcatheter or the rotating hemostasis valve (rhv) cannot be conclusively determined.In addition, it was reported that the concomitant prowler select plus microcatheter was used with the replacement stent to complete the procedure.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.H.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigational findings because the stent component was already detached when the device was received.Functional testing could not be performed.While the premature detachment was confirmed, the time and location when the stent became prematurely detached cannot be conclusively determined.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.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 4.5X14MM STENT 12 MM DW TIP
• 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: 11098606
• MDR Text Key: 228039128
• Report Number: 3008114965-2020-00590
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: ENC451412
• Device Lot Number: 5715051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Age: 52 YR