MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, age, weight, race, ethnicity, and medical history were not provided.Initial reporter information: (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.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 vascular reconstruction for an intracranial stenosis with the target being the moderately tortuous right middle cerebral artery stenosis, the delivery wire on the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 11189603) was fractured, and separated into two pieces during the advancement of the stent in the 0.021¿ prowler select plus microcatheter (catalog# unknown/lot# unknown).The stent was not delivered to the target position due to the fractured delivery wire.It was reported that there was no no difficulty during the advancement of the stent through the microcatheter.The delivery wire was not reshaped prior to use in the patient.The stent was not torqued nor rotated during the attempt to advance it through in the concomitant microcatheter.The physician removed the stent and the concomitant microcatheter from the patient losing the target position.A new stent and a new microcatheter were used, and the physician completed the procedure.The event did not result in any blood flow restriction nor reduction.It did not result in any significant procedural delay.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 11189603 and to include the review of the photo of the complaint device included in the complaint.A photo of the complaint device was included in the complaint.The product analysis lab performed a review of the photo.Based on the photo included in the complaint no appearance of damage could be observed.The stent is noted as still inside the introducer.Only part of the complaint device was shown in the photo.Further investigation will be performed by the product analysis lab when the complaint device is returned.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11189603.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.Further investigation will be performed by the product analysis lab when the complaint device is returned.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 10/12/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the vascular reconstruction for an intracranial stenosis with the target being the moderately tortuous right middle cerebral artery stenosis, the delivery wire on the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 11189603) was fractured and separated into two pieces during the advancement of the stent in the 0.021¿ prowler select plus microcatheter (catalog# unknown/lot# unknown).The stent was not delivered to the target position due to the fractured delivery wire.It was reported that there was no difficulty during the advancement of the stent through the microcatheter.The delivery wire was not reshaped prior to use in the patient.The stent was not torqued nor rotated during the attempt to advance it through in the concomitant microcatheter.The physician removed the stent and the concomitant microcatheter from the patient losing the target position.A new stent and a new microcatheter were used, and the physician completed the procedure.The event did not result in any blood flow restriction nor reduction.It did not result in any significant procedural delay.There was no report of any patient adverse event or complication.The device was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 22mm enterprise® vascular reconstruction device was received contained in a pouch.The returned device was inspected.It was observed that the stent component and the delivery wire were mechanically detached from the rest of the device inside the introducer.No other damage was observed.A photo of the complaint device was included.Per the review from the product analysis lab, the stent was observed still inside the introducer.No appearance of damage could be observed from the photo; only part of the complaint device was shown.The visual inspection of the returned device noted the mechanically detached stent still inside the introducer; this is consistent with the photo that was included in the complaint.Functional analysis could not be conducted; only the stent component was returned mechanically detached inside the introducer.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11189603.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 delivery wire on the device became fractured and separated into two pieces during the advancement of the stent in the concomitant microcatheter.As a result, the stent was not delivered to the target position due to the fractured delivery wire.This was confirmed during the analysis; it was observed that the stent and part of the delivery wire were mechanically detached from the rest of the device.However, the exact time when this occurred cannot be conclusively determined.It was documented in the complaint that the target stenosis was located at the moderately tortuous right middle artery; it is possible that moderately tortuous vessel may have contributed to the issue during the attempt to advance the stent inside the concomitant microcatheter.Force may have been applied during procedure handling that resulted in the stent and delivery wire becoming mechanically detached.Based on the review of the manufacturing documentation, 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: g.4, g.7, h2, 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 4.5X22MM 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: 10537397
• MDR Text Key: 207202133
• Report Number: 3008114965-2020-00389
• 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,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: ENC452212
• Device Lot Number: 11189603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS MICROCATHETER (CERENVOUS).