MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF3575

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.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 3008114965-2020-00470 and 3008114965-2020-00471.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a stenting procedure, a 4.5x22mm enterprise stent delivery system (enc452212, 11195601) became impeded in the 150/5cm prowler select plus microcatheter (606s255x, 30302819).It was reported that the physician found the stent body impeding in microcatheter (mc), then he pulled back the stent system and microcatheter outside of the patient.He found the proximal end of stent body and distal end of delivery wire were ¿wrinkled up¿.The proximal end of the mc hub was wrinkled too.The procedure was completed by a new stent system and microcatheter.There was no patient injury reported.Before the stent entered the microcatheter, the stent connected with the microcatheter¿s hub closely.The y connector was close tightly as well.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch report: b5, d10, g4, g7, h2, h3, h6 and h10.Section b5: additional information received indicated that the user was not able to torque the device.There was no evidence of physical material within the device.No other devices were used with the prowler select mc prior to the encountered resistance.The enterprise stent was the first device to be used with the mc.No excessive force was applied to the devices.The devices were removed from the patient without additional intervention; however, the physician took a lot of power to pull the stent out of the microcatheter.An adequate flush had been maintained through the devices.There was ¿about 20 minutes¿ prolongation during the procedure due to the event, however, it was not clinically significant.The physician stopped this operation and plan to have the operation 2 or 3 months later.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: event description updated with additional information received on 10/20/2020 as reported by the field, during a stenting procedure, a 4.5x22mm enterprise stent delivery system (enc452212, 11195601) became impeded in the 150/5cm prowler select plus microcatheter (606s255x, 30302819).It was reported that the physician found the stent body impeding in microcatheter (mc), then he pulled back the stent system and microcatheter outside of the patient.He found the proximal end of stent body and distal end of delivery wire were ¿wrinkled up¿.The proximal end of the mc hub was wrinkled too.The procedure was completed by a new stent system and microcatheter.There was no patient injury reported.Before the stent entered the microcatheter, the stent connected with the microcatheter¿s hub closely.The y connector was close tightly as well.Additional information received indicated that the user was not able to torque the device.There was no evidence of physical material within the device.No other devices were used with the prowler select mc prior to the encountered resistance.The enterprise stent was the first device to be used with the mc.No excessive force was applied to the devices.The devices were removed from the patient without additional intervention; however, the physician took a lot of power to pull the stent out of the microcatheter.An adequate flush had been maintained through the devices.There was ¿about 20 minutes¿ prolongation during the procedure due to the event, however, it was not clinically significant.The physician stopped this operation and plan to have the operation 2 or 3 months later.A non-sterile unit eu 4.5x22mm stent 12 mm dw tip was received inside of a pouch.The device was inspected, and it was found in good normal conditions, no damages or anomalies were observed during the inspection.A lab sample microcatheter was flushed using a lab sample syringe and after that, the received eu 4.5x22mm stent 12 mm dw tip was introduced into the lab sample microcatheter and it was advance inside it, no resistance/friction was felt during the advancement.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11195601 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 confirmed, during the functional test, the received eu 4.5x22mm stent 12 mm dw tip was introduced into the lab sample microcatheter and it was advance inside it, no resistance/friction was felt during the advancement.The complaint reported by the customer ¿distal tip (delivery wire) - kinked/bent¿ was not confirmed, during the analysis, it was noted that the device was returned in good normal conditions, no damages or anomalies were observed during the analysis.The complaint reported by the customer ¿stent - kinked/bent - in patient¿ was not confirmed, during the analysis, it was noted that the device was returned in good normal conditions, no damages or anomalies were observed during the analysis.Neither the analysis nor the mre suggests that the failure reported by the customer could not be related to the manufacturing process.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the events 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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: EU 4.5X22MM 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: 10705153
• MDR Text Key: 228520899
• Report Number: 3008114965-2020-00470
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009495
• UDI-Public: 10878528009495
• 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
• Report Date: 09/28/2020

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 Model Number: 641CF3575
• Device Catalogue Number: ENC452212
• Device Lot Number: 11195601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM