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

Model Number	641CF0925
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.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.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 1226348-2020-00034.
Event or Problem Description
As reported by a healthcare professional, a 4mmx23mm enterprise2 no tip stent delivery system (enc402300,10998144), was inserted into a concomitant microcatheter, 150/5cm 45tip prowler sel plus (606s255fx, 30296214) but there was intensive resistance felt at 5cm from the distal tip.It was not able to be advanced anymore.It was removed from the patient and replaced with another device and the procedure was completed.The customer states there is no additional information available.Pre-shipment pictures of the prowler select plus microcatheter were received.
Additional 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 a healthcare professional, a 4mmx23mm enterprise2 no tip stent delivery system (enc402300,10998144), was inserted into a concomitant microcatheter, a 150/5cm 45tip prowler sel plus (606s255fx, 30296214) but there was intensive resistance felt at 5 cm from the distal tip.It was not able to be advanced anymore.It was removed from the patient and replaced with another device and the procedure was completed.The customer states there is no additional information available.The device was discarded; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 10998144.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint of ¿delivery wire - impeded in microcatheter with loss of cerebral target position¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Per the instructions for use (ifu) advance the distal end of the introducer into the rhv connected to the infusion catheter until it is fully engaged with the infusion catheter hub (0.021" prowler select plus infusion catheter), then tighten the rhv locking ring.Flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.The ifu warns to purge the device carefully to avoid the accidental introduction of air into the system.It also warns to confirm that there are no air bubbles trapped anywhere in the system.The introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.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.Do 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 without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 4MMX23MM 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: 9978341
• Report Number: 1226348-2020-00033
• Device Sequence Number: 3329793
• Product Code: NJE
• UDI-Device Identifier: 10878528009648
• UDI-Public: 10878528009648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 641CF0925
• Device Catalogue Number: ENC402300
• Device Lot Number: 10998144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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: PROWLER SEL PLUS 150/5CM 45TIP