MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11183936.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.

Event Description

The healthcare professional reported that during the procedure to treat an intracranial arterial stenosis, the 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412 /1183936) was being advanced inside the concomitant 150cm x 5cm prowler select plus microcatheter ((b)(4) / lot# unknown) when it prematurely deployed inside the microcatheter.The physician withdrew the stent system and the microcatheter from the patient¿s body.A new stent and a new microcatheter were used to complete the procedure.There was no report of any patient adverse event or injury.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to correct the initial reporter address.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 11/5/2020.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the procedure to treat an intracranial arterial stenosis, the 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412 / 1183936) was being advanced inside the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) when it prematurely deployed inside the microcatheter.The physician withdrew the stent system and the microcatheter from the patient¿s body.A new stent and a new microcatheter were used to complete the procedure.There was no report of any patient adverse event or injury.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 14mm enterprise® vascular reconstruction device was received contained in a pouch.Visual inspection was performed.It was noted that the stent component was detached from the rest of the device.The delivery wire and the introducer were in good condition.Functional evaluation could not be performed as the stent component was returned deatached from the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11183936.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The complaint documented that during the procedure, the 4.5mm x 14mm enterprise® vascular reconstruction device was being advanced inside the concomitant microcatheter when it prematurely deployed inside the microcatheter.The returned device has the stent component detached from the device; functional evaluation was precluded as the stent was already detached.Although the stent was detached from the rest of the device, there was no evidence that it detached in the microcatheter because only the stent and its respective component were returned for evaluation.The issue documented in the complaint related to the premature deployment of the stent was confirmed based on the detached condition of the returned device and the stent component.Based on the device history record 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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.Updated sections: d.10, g.4.G.7, h.2, h.3, h.6, and h.10.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: EU 4.5X14MM STENT 12 MM DW 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
• MDR Report Key: 10735534
• MDR Text Key: 213258905
• Report Number: 3008114965-2020-00457
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: ENC451412
• Device Lot Number: 11183936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM.