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

Model Number 641CF0925

Device Problems Premature Activation (1484); 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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, 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 3008114965-2020-00245.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11157431.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.No apparent damage could be appreciated on the picture received.Only a part of the device was shown.The reported condition ¿delivery wire -impeded in microcatheter with loss of cerebral target position¿ could not be evaluated based on the pictures.Further investigation will be performed if the device returns for analysis.

Event Description

As reported by the field, a 150/5cm prowler select plus microcatheter (606s255fx, 30299292) was delivered to the lesion.Then a 4mmx23mm enterprise2 stent delivery system (enc402300, 11157431) was inserted into the microcatheter (mc) but there was a strong resistance felt and it was not able to advance through the mc.The stent of the enterprise2 did not deploy inside the patient.They were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure completed.There was no reported patient injury.It is unclear which part of the microcatheter the resistance occurred.Additional information was received indicating that the complaint stent was inserted into the complaint microcatheter to implant the complaint stent.The microcatheter came out from the lesion.The physician attempted to re-sheath the complaint stent as per the instructions for use (ifu) but it was implanted inside the complaint microcatheter and the stent was not able to be re-sheathed.The physician requested the investigation of the distal delivery wire which had stent part.The customer states there is no additional information available.Pictures were provided.

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.Section b5: additional information was received indicating that the complaint stent was inserted into the complaint microcatheter to implant the complaint stent.The microcatheter came out from the lesion.The physician attempted to re-sheath the complaint stent as per the instructions for use (ifu) but it was implanted inside the complaint microcatheter and the stent was not able to be re-sheathed.The customer states there is no additional information available.Complaint conclusion: as reported by the field, a 150/5cm prowler select plus microcatheter (606s255fx, 30299292) was delivered to the lesion.Then a 4mmx23mm enterprise2 stent delivery system (enc402300, 11157431) was inserted into the microcatheter (mc) but there was a strong resistance felt and it was not able to advance through the mc.The stent of the enterprise2 did not deploy inside the patient.They were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure completed.There was no reported patient injury.It is unclear which part of the microcatheter the resistance occurred.Additional information was received indicating that the complaint stent was inserted into the complaint microcatheter to implant the complaint stent.The microcatheter came out from the lesion.The physician attempted to re-sheath the complaint stent as per the instructions for use (ifu) but it was implanted inside the complaint microcatheter and the stent was not able to be re-sheathed.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 stent was found deployed inside the hub of the prowler select microcatheter received.The functional analysis could not be performed due the stent was returned deployed for analysis.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11157431.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 ¿stent - deployment difficulty-premature/in microcatheter hub¿ was confirmed due the stent was found deployed inside of the microcatheter hub.The complaint reported by the customer "delivery wire- impeded in microcatheter with loss of cerebral target position" was not able to be confirmed, the functional test was not able to be performed due the conditions of the received device (stent deployed).Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (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.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Of note, the device was being used off-label to treat carotid artery stenosis.According to the ifu, the enterprise stent is intended for use with occlusive devices in the treatment of intracranial aneurysms and is not intended as a stand-alone device.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional information received on 11-aug-2020 indicated that the introducer was placed securely in the hub prior to attempting to advance the delivery wire.The devices were inspected and prepped per ifu.There was nothing unusual noted about the stent delivery system prior to use.There were no surgical delays due to the event.No excessive force was applied at any time.Adequate flush was maintained through the devices.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.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional information received, indicated that there was continuous flush maintained with the microcatheter.There was no excessive force been 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 on 7/28/2020 as reported by the field, a 150/5cm prowler select plus microcatheter (606s255fx, 30299292) was delivered to the lesion.Then a 4mmx23mm enterprise2 stent delivery system (enc402300, 11157431) was inserted into the microcatheter (mc) but there was a strong resistance felt and it was not able to advance through the mc.The stent of the enterprise2 did not deploy inside the patient.They were replaced with another prowler select plus and enterprise 2.The enterprise 2 was implanted without any problems.The procedure completed.There was no reported patient injury.It is unclear which part of the microcatheter the resistance occurred.Additional information was received indicating that the complaint stent was inserted into the complaint microcatheter to implant the complaint stent.The microcatheter came out from the lesion.The physician attempted to re-sheath the complaint stent as per the instructions for use (ifu) but it was implanted inside the complaint microcatheter and the stent was not able to be re-sheathed.Additional information received, indicated that there was continuous flush maintained with the microcatheter.There was no excessive force been 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 stent was found deployed inside the hub of the prowler select microcatheter received.The functional analysis could not be performed due the stent was returned deployed for analysis.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11157431.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 ¿stent - deployment difficulty-premature/in microcatheter hub¿ was confirmed due the stent was found deployed inside of the microcatheter hub.The complaint reported by the customer "delivery wire- impeded in microcatheter with loss of cerebral target position" was not able to be confirmed, the functional test was not able to be performed due the conditions of the received device (stent deployed).Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (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.Deployment difficulty is a known potential product failure associated with the use of the device.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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: 10157567
• MDR Text Key: 195251200
• Report Number: 3008114965-2020-00244
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 641CF0925
• Device Catalogue Number: ENC402300
• Device Lot Number: 11157431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SEL PLUS 150/5CM 45TIP.; PROWLER SEL PLUS 150/5CM 45TIP