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

Model Number	ENF403000
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during the procedure, the physician felt strong resistance during the attempt to advance the 4.0mm dia x 30mm with no tip enterprise®2 (enf403000 / 11175283) through the hub of the microcatheter (unspecified brand).The stent was removed and replaced.The procedure was successfully completed.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 30-jun-2022, the event has been deemed reportable as a "malfunction.".
Additional Manufacturer Narrative
(b)(4).The initial reporter phone and email address are not available / reported.[conclusion]: the healthcare professional reported that during the procedure, the physician felt strong resistance during the attempt to advance the 4.0mm dia x 30mm with no tip enterprise®2 (enf403000 / 11175283) through the hub of the microcatheter (unspecified brand).The stent was removed and replaced.The procedure was successfully completed.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.0mm dia x 30mm with no tip enterprise®2 was received contained in a decontamination pouch.Visual inspection was performed.The stent component was observed detached from the delivery wire.The introducer was observed in good, normal condition (without any kinks and without any splits).Microscopic inspection was performed.Under magnification, the delivery wire was noted to be bent just distal and just proximal to the marker band.On the stent component, one of the marker bands was noted to be bent, and a strut was found to be broken off.No other structural damages or anomalies were noted on the struts or the rest of the marker bands.Due to the condition of the returned device with the stent already separated from the delivery wire, and due to the structural damage noted on both components, the device could not be submitted to functional testing.However, the damages noted on the stent and delivery wire are reasonably suspected to be secondary to the resistance encountered during the procedure due to the manipulation required to move the stent.At this time, it is only known that the enterprise device was replaced.It is possible that undue force may have been applied during the stent removal from the microcatheter, or that it might have gotten caught with the microcatheter hub; however, the microcatheter was not submitted to evaluation and product information is unknown.Due to the limited information available for review, a root cause cannot be assigned, and no contributing factors could be identified from the returned component.The reported issue documented in the complaint was confirmed.However, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.(b)(4) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11175283.The history record indicates this product was final inspection tested at (b)(4) medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.¿ if resistance is met during manipulation, determine the cause of resistance before proceeding.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14881810
• Report Number: 3008114965-2022-00474
• Device Sequence Number: 5189303
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: 07/28/2022
• Device Model Number: ENF403000
• Device Catalogue Number: ENF403000
• Device Lot Number: 11175283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown