MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF0925

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00241.

Event Description

As reported by the field, a 4mmx23mm enterprise2 stent delivery system (enc402300, 11004261) was inserted into a 150/5cm prowler select plus microcatheter (606s255fx, 17745485) but there was a strong resistance felt and it was not able to advance through the microcatheter (mc).It occurred when the stent was approximate 3 cm from the distal end of the mc.The stent did not deploy inside the patient.The devices were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure was completed.There was no reported patient injury.The customer states there is no additional information available.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this report: g4, g7, h2, and h10.Pictures of the enterprise2 4mmx23mm no tip were received on 07-sep-2020.Based on the visual analysis of the photos provided, no apparent damage could be appreciated on the picture.The enterprise could be noted partially inside of a mc.The actual product was received and analyzed.The results were included in report mwr-29072020-0000773747.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, a 4mmx23mm enterprise2 stent delivery system (enc402300, 11004261) was inserted into a 150/5cm prowler select plus microcatheter (606s255fx, 17745485) but there was a strong resistance felt and it was not able to advance through the microcatheter (mc).It occurred when the stent was approximate 3 cm from the distal end of the mc.The stent did not deploy inside the patient.The devices were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure was completed.There was no reported patient injury.The customer states there is no additional information available.One non-sterile unit enterprise2 4mmx23mm no tip was received inside of a pouch.The received device was visually inspected, the device was found in good conditions.Then a microscopic inspection was performed, no damages were observed.The received prowler sel plus 150/5cm 45tip 376 was flushed using a lab sample syringe.After that, the unit enterprise2 4mmx23mm no tip was introduced into the received microcatheter and advanced, no resistance/friction was felt.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11004261.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ was not able to be confirmed.On the functional test, the device was able to pass through the involved mc without difficulty.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The ifu instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional information received indicated that the target site was the internal carotid artery, unruptured cerebral aneurysm.The event did not result in loss of cerebral target position.Continuous flush on the microcatheter was maintained.No excessive force was applied to the device.Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion updated with additional information received: as reported by the field, a 4mmx23mm enterprise2 stent delivery system (enc402300, 11004261) was inserted into a 150/5cm prowler select plus microcatheter (606s255fx, 17745485) but there was a strong resistance felt and it was not able to advance through the microcatheter (mc).It occurred when the stent was approximate 3 cm from the distal end of the mc.The stent did not deploy inside the patient.The devices were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure was completed.There was no reported patient injury.Additional information received indicated that the target site was the internal carotid artery, unruptured cerebral aneurysm.The event did not result in loss of cerebral target position.Continuous flush on the microcatheter was maintained.No excessive force was applied to the device.One non-sterile unit enterprise2 4mmx23mm no tip was received inside of a pouch.The received device was visually inspected, the device was found in good conditions.Then a microscopic inspection was performed, no damages were observed.The received prowler sel plus 150/5cm 45tip 376 was flushed using a lab sample syringe.After that, the unit enterprise2 4mmx23mm no tip was introduced into the received microcatheter and advanced, no resistance/friction was felt.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11004261.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ was not able to be confirmed.On the functional test, the device was able to pass through the involved mc without difficulty.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The ifu instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.

• Brand Name: ENTERPRISE2 4MMX23MM NO 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: 10153265
• MDR Text Key: 227946685
• Report Number: 3008114965-2020-00240
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009648
• UDI-Public: 10878528009648
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 641CF0925
• Device Catalogue Number: ENC402300
• Device Lot Number: 11004261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SEL PLUS 150/5CM 45TIP.