MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC401600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Event Description

It was reported, via a personal interaction, that an enterprise2 4mmx16mm no tip (enc401600/lot # unknown) were used for a stent-assisted coil embolization of a ruptured dissecting aneurysm at right posterior cerebral artery.During the postoperative hospitalization period, a thrombus in the stent was found, intravenous ozagrel was administrated.The thrombus gradually disappeared during hospitalization.The patient was discharged with no neurological deficits.The event was reported as such, ¿the procedure was a stent-assisted coil embolization of a ruptured dissecting aneurysm at right posterior cerebral artery.The patient was 60 years, female.She developed a sudden severe headache and loss of consciousness and was taken to the hospital.Ct showed severe subarachnoid hemorrhage.Digital subtraction angiography confirmed a dissecting aneurysm in p2 segment of the right posterior cerebral artery.A stent-assisted coil embolization of a ruptured dissecting aneurysm was performed.The enterprise 2 was implanted during the procedure.The procedure was completed.During the postoperative hospitalization period, a thrombus in the stent was found, intravenous ozagrel was administrated.The thrombus gradually disappeared during hospitalization.The patient was discharged with no neurological deficits.6 months after the procedure, the patient had no neurologic deficit nor stent occlusion.Continuous flush was unknown.The lesion was p2 segment of the right posterior cerebral artery.Other concomitant device was prowler select plus microcatheter.¿ additional information was received on 23-apr-2024.Summary: regarding what the physician thinks may have caused or contributed to the vent; this information was unobtainable.Regarding if the thrombus was flow limiting, this information was unobtainable.It was confirmed the thrombus was located inside the stent.No further information was made available.

Manufacturer Narrative

Product complaint (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.B.3 ¿ date of event: the date of the event was not reported.D.4: the product lot number is not available / not reported.The expiration date of the device is not known.E.1: initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.The device remains implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Cerebral thrombosis is a known potential complication associated with the enterprise2 stent and is mentioned in the instructions for use (ifu) as such.There were no alleged quality issues related to the used device, as the device performed as intended.In this case, the event required intravenous medication to preclude patient harm.Therefore, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ENTERPRISE2 4MMX16MM 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
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19191605
• MDR Text Key: 341145462
• Report Number: 3008114965-2024-00434
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENC401600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female