MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC403000

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

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.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization targeting a cerebral aneurysm, the 4.0mm x 30mm enterprise® 2 vascular reconstruction device (enc403000 / 11017351) encountered resistance in the 150cm x 5cm prowler select plus microcatheter (606s255x / 30215961).The stent and microcatheter were removed as a unit from the patient and replaced with other devices to complete the procedure.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11017351.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 available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, the aneurysm size / vessel characteristics may have contributed to the reported issue.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00027.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 stent-assisted coil embolization targeting a cerebral aneurysm, the 4.0mm x 30mm enterprise® 2 vascular reconstruction device (enc403000 / 11017351) encountered resistance in the 150cm x 5cm prowler select plus microcatheter (606s255x / 30215961).The stent and microcatheter were removed as a unit from the patient and replaced with other devices to complete the procedure.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr is to include the additional event information received on (b)(6)2020.E.1: the initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during the stent-assisted coil embolization targeting a cerebral aneurysm, the 4.0mm x 30mm enterprise® 2 vascular reconstruction device (enc403000 / 11017351) encountered resistance in the 150cm x 5cm prowler select plus microcatheter (606s255x / 30215961).The stent and microcatheter were removed as a unit from the patient and replaced with other devices to complete the procedure.The reported issue did not result in any procedural delay.There was no report of any patient adverse event or complication.Updated sections: e.1, e.3, g.4, g.7, h.2, and h.10.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2020-00027 and 1226348-2020-00028.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 4MMX30MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 9958230
• MDR Text Key: 204955748
• Report Number: 1226348-2020-00028
• 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
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: ENC403000
• Device Lot Number: 11017351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM