MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problem Failure to Advance (2524)

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

Event Date 11/03/2020

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.(b)(6) medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11192230.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2020-00531 and 3008264254-2020-00005.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 angiography of the whole blood vessel and a stent-assisted coil embolization procedure, it was reported that the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812 / 11192230) could not advance within the distal prowler select plus microcatheter (catalog# unknown / lot # unknown).The physician withdrew the stent system and replaced the microcatheter, but the stent could not move in the new, replacement microcatheter.The physician replaced the stent with another 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812) and successfully completed the procedure.Additional information was received that indicated that the introducer of the enterprise stent system was fully seated and secure in the microcatheter hub.Adequate and continuous flush was maintained through the microcatheter.There was nothing unusual noted about the system prior to use.The microcatheter did not have any appearance of kinks or other damages.The stent and the stent delivery system did not appear damaged when it was removed from the microcatheter.The new replacement enterprise stent system was used with the replacement microcatheter to complete the procedure.There was no procedure delay from the reported event.There was no report of any patient adverse event or complication as a result of the reported event.

Manufacturer Narrative

Manufacturer¿s ref no: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 12/18/2020.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the angiography of the whole blood vessel and a stent-assisted coil embolization procedure, it was reported that the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812 / 11192230) could not advance within the distal prowler select plus microcatheter (catalog#: unknown / lot#: unknown).The physician withdrew the stent system and replaced the microcatheter, but the stent could not move in the new, replacement microcatheter.The physician replaced the stent with another 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812) and successfully completed the procedure.Additional information was received that indicated that the introducer of the enterprise stent system was fully seated and secure in the microcatheter hub.Adequate and continuous flush was maintained through the microcatheter.There was nothing unusual noted about the system prior to use.The microcatheter did not have any appearance of kinks or other damages.The stent and the stent delivery system did not appear damaged when it was removed from the microcatheter.The new replacement enterprise stent system was used with the replacement microcatheter to complete the procedure.There was no procedure delay from the reported event.There was no report of any patient adverse event or complication as a result of the reported event.The complaint device was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 28mm enterprise® vascular reconstruction device was received contained in a pouch.Visual inspection was performed.Only the delivery wire was returned, and it was observed to be in good condition.Functional evaluation could not be conducted only the delivery wired returned.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 11192230.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint documented that the 4.5mm x 28mm enterprise® vascular reconstruction device could not advance within the distal part of the prowler select plus microcatheter.The reported issue could not be confirmed through functional evaluation as only the delivery wire was returned.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2020-00531 and 3008264254-2020-00005.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 4.5X28MM 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: 10969372
• MDR Text Key: 250092587
• Report Number: 3008114965-2020-00531
• 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
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: ENC452812
• Device Lot Number: 11192230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER.