MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF1030
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 3008114965-2021-00110 and 1226348-2021-00014.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a stent assist coil embolization of a wide neck of the basilar artery, a prowler select plus microcatheter (product/lot number unknown) was delivered to the left posterior cerebral artery (pca) from a 5f envoy guiding catheter.A 23mm enterprise stent was used for implantation, but the length was not enough to cover the neck.Therefore, it was replaced with a 4mmx30mm enterprise2 no tip stent (enc403000, 5711194).It was attempted to be implanted from the prowler select plus (psp) but there was a resistance felt to deploy at the catheter.The complaint stent delivery system was removed from the patient.The microcatheter was replaced with a sl10, stryker microcatheter (mc) and a neuroform atlas stent, stryker was used.The procedure continued.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that continuous flush on the microcatheter was maintained.No excessive force was applied to the device.There was no prolongation in the procedure due to the event.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: as reported by the field, during a stent assist coil embolization of a wide neck of the basilar artery, a prowler select plus microcatheter (product/lot number unknown) was delivered to the left posterior cerebral artery (pca) from a 5f envoy guiding catheter.A 23mm enterprise stent was used for implantation, but the length was not enough to cover the neck.Therefore, it was replaced with a 4mmx30mm enterprise2 no tip stent (enc403000, 5711194).It was attempted to be implanted from the prowler select plus (psp) but there was a resistance felt to deploy at the catheter.The complaint stent delivery system was removed from the patient.The microcatheter was replaced with a sl10, stryker microcatheter (mc) and a neuroform atlas stent, stryker was used.The procedure continued.Additional information received indicated that continuous flush on the microcatheter was maintained.No excessive force was applied to the device.There was no prolongation in the procedure due to the event.A non-sterile unit enterprise2 4mmx30mm no 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.During the functional analysis, a lab sample microcatheter was flushed using a lab sample syringe and after that, the received enterprise2 4mmx30mm no tip was introduced into the lab sample micro-catheter and it was advance inside it, no resistance/friction was felt during the advancement.Also, no problem was observed during the deployment process.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of lot 5711194.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported customer complaint of ¿delivery wire - resistance/friction with loss of mc cerebral target position¿ could not be confirmed as the functional test on the enterprise2 4mmx30mm no tip was performed without any difficulties.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) do contain the following caution: if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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: ENTERPRISE2 4MMX30MM NO TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11445287
• Report Number: 3008114965-2021-00110
• Device Sequence Number: 14357055
• Product Code: NJE
• UDI-Device Identifier: 10878528009655
• UDI-Public: 10878528009655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 641CF1030
• Device Catalogue Number: ENC403000
• Device Lot Number: 5711194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F ENVOY GUIDING CATHETER; UNKPROWLERSELECT