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

Catalog Number ENC402300

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that a (b)(6) year-old female with a past medical history of hypertension underwent a stent assisted coil embolization about 5 years ago to treat a basilar artery (ba) main trunk aneurysm (neck size, 4.6 mm, dome 7.8 mm, height 8.6 mm) using a 4mmx23mm no tip enterprise 2 stent (enc402300/unknown lot#) and 3 years later experienced aneurysm recanalization.The abstract reports, ¿the aneurysm was again enlarged, so we decided to add a coil embolization using a stent.¿ there are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is the enterprise 2 stent.Other cnv webster devices that were also used in this study: none.Non-cnv webster devices that were also used in this study: unknown brand coils.Publication details.Title: a case of recurrent large basilar artery aneurysm treated with overlap stent.Objective: endovascular treatment is often indicated for basilar artery (ba) aneurysm because of difficulty in direct access but the treatment strategy is often difficult.Methods: review of case report.

• Brand Name: ENTERPRISE2 4MMX23MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine 92618 ; 9497898687
• MDR Report Key: 12046949
• MDR Text Key: 261056640
• Report Number: 3008114965-2021-00258
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

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: ENC402300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR