MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF1230

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

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.The name, phone and email address of the initial reporter are not available / reported.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the 4.0mm x 39mm enterprise® 2 vascular reconstruction device ((b)(4)) was used during the procedure targeting a lesion, which has a wide neck.The physician attempted to implant the stent, but resheathed it once in order to change the implantation position.During the attempt to deploy the stent, it became stuck in the concomitant prowler select plus microcatheter, and as a result, could not be implanted.The physician removed the microcatheter with the stent inside.The stent was replaced, and the replacement stent was implanted.Due to infectious disease, the complaint device is not available for return.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to document the result of the analysis of the production records for lot 11146764.[conclusion]: the healthcare professional reported that the 4.0mm x 39mm enterprise® 2 vascular reconstruction device (enc403900 / 11146764) was used during the procedure targeting a lesion which has a wide neck.The physician attempted to implant the stent, but resheathed it once in order to change the implantation position.During the attempt to deploy the stent, it became stuck in the concomitant prowler select plus microcatheter and as a result, could not be implanted.The physician removed the microcatheter with the stent inside.The stent was replaced, and the replacement stent was implanted.Due to infectious disease, the complaint device is not available for return.There was no report of any patient adverse event or complication.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11146764.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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product and concomitant microcatheter available for analysis, the reported customer complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation/interaction may have contributed to the reported failure.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 10/1/2020.[additional event information]: the healthcare professional reported that the 4.0mm x 39mm enterprise® 2 vascular reconstruction device (enc403900 / 11146764) was used during the procedure targeting a lesion on the internal carotid artery (ica) which has a wide neck.The physician attempted to implant the stent, but resheathed it once in order to change the implantation position.During the attempt to deploy the stent, it became stuck in the concomitant prowler select plus microcatheter and as a result, could not be implanted.The physician removed the microcatheter with the stent inside.The stent was replaced, and the replacement stent was implanted.The reported event did not result in reduced / restricted blood flow in the parent vessel.The event did not cause prolongation of the procedure nor any clinically significant procedural delay.Due to infectious disease, the complaint device is not available for return.There was no report of any patient adverse event or complication.E.1: the initial reporter phone: +(b)(6).Updated sections: e.1, e.3, g.4, g.7, h.2, 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: ENTERPRISE2 4MMX39MM 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
• MDR Report Key: 10568255
• MDR Text Key: 208160479
• Report Number: 3008114965-2020-00401
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009662
• UDI-Public: 10878528009662
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 641CF1230
• Device Catalogue Number: ENC403900
• Device Lot Number: 11146764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS MICROCATHETER (CERENOVUS).