MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF3509

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).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 3008114965-2020-00234.

Event Description

As reported by the field, during an intracranial aneurysm embolization, the delivery wire of a 4.5mmd 22mml enterprise stent delivery system (enc452200, 11186590) was detached from stent body.It was reported that when the stent was advancing in the 150/5cm prowler select plus microcatheter (606s255x, 30272527), the physician found the delivery wire was totally detached from the stent.Then he withdrew the stent and microcatheter (mc) together outside of the patient.The physician used a new enterprise stent (code: ecr452212) and a new prowler select mc (code: 606s255x) to complete the procedure.The target cerebral position was lost.There was no patient injury reported.The blood vessels are abnormally tortuous.The physician thought the stent was detached from its delivery wire when it crossed a sharp bend of blood vessels.

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, during an intracranial aneurysm embolization, the delivery wire of a 4.5mmd 22mml enterprise stent delivery system (enc452200, 11186590) was detached from the stent body.It was reported that when the stent was advancing in the 150/5cm prowler select plus microcatheter (606s255x, 30272527), the physician found the delivery wire was totally detached from the stent.Then he withdrew the stent and microcatheter (mc) together outside of the patient.The physician used a new enterprise stent (code: ecr452212) and a new prowler select mc (code: 606s255x) to complete the procedure.The target cerebral position was lost.There was no patient injury reported.The blood vessels are abnormally tortuous.The physician thought the stent was detached from its delivery wire when it crossed a sharp bend of blood vessels.One non-sterile unit eu ent4.5mmd 22mml wno dstl tp was received inside of a pouch.The received device was visually inspected, only the delivery wire was returned for evaluation and it was found in good normal conditions.The functional analysis could not be performed due only the delivery wire was returned 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 11186590.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 not able to confirm.The functional analysis could not be performed as the stent was not returned for evaluation.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 event remains speculative and inconclusive based on the minimal 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.There are possible vessel characteristics, specifically that the patient¿s blood vessels were abnormally tortuous, and the sharp bend of blood vessels might have contributed the reported failure.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.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional information received indicated that there was no resistance felt within the mc.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.The devices were stored, inspected and prepped per instructions for use (ifu).Nothing unusual was 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.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: as reported by the field, during an intracranial aneurysm embolization, the delivery wire of a 4.5mmd 22mml enterprise stent delivery system (enc452200, 11186590) was detached from stent body.It was reported that when stent was advancing in the 150/5cm prowler select plus microcatheter (606s255x, 30272527), the physician found the delivery wire was totally detached from the stent.Then he withdrew the stent and microcatheter (mc) together outside of the patient.The physician used a new enterprise stent (code: ecr452212) and a new prowler select mc (code: 606s255x) to complete the procedure.The target cerebral position was lost.There was no patient injury reported.The blood vessels are abnormally tortuous.The physician thought the stent was detached from its delivery wire when it crossed a sharp bend of blood vessels.Additional information received indicated that there was no resistance felt within the mc.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.The devices were stored, inspected and prepped per instructions for use (ifu).Nothing unusual was 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.One non-sterile unit eu ent4.5mmd 22mml wno dstl tp was received inside of a pouch.The received device was visually inspected, only the delivery wire was returned for evaluation and it was found in good normal conditions.The functional analysis could not be performed due only the delivery wire was returned 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 11186590.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 not able to confirm.The functional analysis could not be performed as the stent was not returned for evaluation.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 event remains speculative and inconclusive based on the minimal 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.There are possible vessel characteristics, specifically that the patient¿s blood vessels were abnormally tortuous, and the sharp bend of blood vessels might have contributed the reported failure.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 ENT4.5MMD 22MML WNO DSTL TP
• 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: 10128552
• MDR Text Key: 208319443
• Report Number: 3008114965-2020-00233
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• 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
• Report Date: 05/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 11186590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM.