MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF3509

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

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 facility name: (b)(6).Initial reporter phone: (b)(6).The initial reporter email address is not available / was not reported.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 6253757.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of three (3) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00207 and 3008114965-2021-00215.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a stent-assisted coil embolization procedure, after the physician implanted a medtronic coil, he inserted the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (enc452200 / 6253757) and delivered it to the target position via the 150cm x 5cm prowler select plus (606s255x / 30487605).When the stent component was half deployed, the physician thought the position should be adjusted.He planned to withdraw the stent back into the microcatheter, but the attempt was not successful.The physician withdrew the stent and the microcatheter from the patient.Outside the patient¿s body, the microcatheter was observed bent.The physician switched to a new stent (medtronic) and microcatheter to complete the procedure.There was no report of any patient adverse event or complication as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 21 june 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of three (3) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00207, 3008114965-2021-00214, and 3008114965-2021-00215.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 a stent-assisted coil embolization procedure, after the physician implanted a medtronic coil, he inserted the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (enc452200 / 6253757) and delivered it to the target position via the 150cm x 5cm prowler select plus (606s255x / 30487605).When the stent component was half deployed, the physician thought the position should be adjusted.He planned to withdraw the stent back into the microcatheter, but the attempt was not successful.The physician withdrew the stent and the microcatheter from the patient.Outside the patient¿s body, the microcatheter was observed bent.The physician switched to a new stent (medtronic) and microcatheter to complete the procedure.There was no report of any patient adverse event or complication as a result of the reported issue.The complaint device was returned for evaluation and analysis; the investigational finding is documented below.Investigation summary: a non-sterile 150cm x 5cm prowler select plus microcatheter was received coiled inside a pouch with the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device stuck inside it.The enterprise stent could not be removed from the microcatheter.Functional analysis: the 150cm x 5cm prowler select plus microcatheter was flushed with warm water in attempt to remove the enterprise stent.However, the stent could not be removed from the microcatheter.X-ray inspection was performed to check on the condition of the stent.The stent was observed still attached to the delivery wire; the braided mesh portion of the stent is without any appearance of damage.The microcatheter was then dissected at the occluded section.It was then observed that the enterprise stent component was stuck due to residues of dried saline solution.Warm water was placed on the areas with the saline residues, but only part of the saline residues were dissolved; the stent component remained stuck in the microcatheter.This precluded the device from undergoing functional test.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6253757.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint documented that the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device was used during the stent-assisted coil embolization procedure; when the physician inserted the stent and delivered it to the target position, when the stent was half-deployed, the physician attempted to readjust the position and was trying to withdraw the stent back into the microcatheter but the attempt to retract the stent was not successful.Based on the stent component being stuck inside the microcatheter and not able to be removed from it, the reported issue was confirmed.The residues of the dried saline solution indicate that flushing during the procedure may not have been adequately maintained through the microcatheter during the procedure.It should be noted that product failure is multifactorial, the instructions for use (ifu) contain the following warnings and recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Based on the manufacturing documentation 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 was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of three (3) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00207, and 3008114965-2021-00215.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 ENT4.5MMD 22MML WNO DSTL TP
• 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: 11958009
• MDR Text Key: 280957385
• Report Number: 3008114965-2021-00214
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• 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: 05/18/2021

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: 01/28/2023
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 6253757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 07/22/2021
• Supplement Dates FDA Received: 06/21/2021; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRESIDIO 10 CERE 5MMX17CM; PROWLER SELECT PLUS 150/5CM