MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problems Transient Ischemic Attack (2109); Obstruction/Occlusion (2422)

Event Type  Injury  

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 catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section 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.Stent occlusion resulting in cerebral ischemia 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 devices, as the devices performed as intended.The modified rankin scale (mrs) measures the degree of disability/dependence after a stroke.Since the patient¿s mrs score decreased by ¿more than 1,¿ this event does meet the criteria of a serious injury.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 is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00431.

Event Description

It was reported, via a personal interaction, that two unknown enterprise2 stents (product code/lot # unknown) were used for a stent-assisted coil embolization of a ruptured saccular middle cerebral artery aneurysm.During the procedure, the user reported a stent-related ischemic complication developed and the patient¿s mrs decreased by more than 1.The event was reported as such, ¿the procedure was a stent-assisted coil embolization of a ruptured saccular middle cerebral artery aneurysm.2 stents of the enterprise 2 were implanted during the procedure.Stent occlusion and stent-related ischemic complication developed and mrs decreased by more than 1.Detailed information on the post-procedure patient¿s condition was unobtainable.Continuous flush was unknown.The lesion was middle cerebral artery.Other concomitant devices were unknown.¿ additional information was received on 23-apr-2024.Summary: per the information provided, regarding what the physician thinks may have caused or contributed to the event, it was commented, ¿stenosis and ischemic complication was related to stent implantation.¿ regarding if the event occurred intra-procedurally, if the thrombus was located within 5mm of the enterprise2 stent, the patient¿s baseline neurological status, how the event was treated, and if symptoms resolved, were all unobtainable information.No further information was made available.

• Brand Name: UNKENTERPRISE2
• 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: 19190408
• MDR Text Key: 341122631
• Report Number: 3008114965-2024-00432
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKENTERPRISE2
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male