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

Model Number	641CF3509
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an intracranial ischemic procedure with the target position at the middle cerebral artery (mca), the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (enc452200 / 6253765) could not be advanced nor withdrawn in the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30447565) after the stent arrived in the target position through the microcatheter.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication as a result of the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter first name is not available.The initial reporter phone: (b)(6).The initial reporter email address is not available / 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 6253765.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00336 and 3008114965-2021-00337.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.
Additional 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 01 september 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.9, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00336 and 3008114965-2021-00337.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25 august 2021.[additional information]: the healthcare professional reported that during an intracranial ischemic procedure with the target position at the middle cerebral artery (mca), the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (enc452200 / 6253765) could not be advanced nor withdrawn in the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30447565) after the stent arrived in the target position through the microcatheter.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication as a result of the reported issue.Additional information was received on 25 august 2021.The information indicated that there were no visible kinks and no other damages observed on the microcatheter.The stent component of the enterprise device was still on the delivery wire when it was removed from the patient.There was nothing unusual noted on the microcatheter nor on the enterprise device system prior to use.Adequate and continuous flush was maintained through the microcatheter.The reported issue did not result in any procedure delay.The physician completed the procedure using another enterprise system and another prowler select plus microcatheter.Updated sections: a.2, a.3, a.4, g.3, g.6, h.2, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00336 and 3008114965-2021-00337.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.
Additional 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 an intracranial ischemic procedure with the target position at the middle cerebral artery (mca), the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (enc452200 / 6253765) could not be advanced nor withdrawn in the 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30447565) after the stent arrived in the target position through the microcatheter.The physician withdrew the stent and the microcatheter together from the patient.A new microcatheter and a new stent were used to complete the procedure.There was no report of any patient adverse event or complication as a result of the reported issue.Additional information was received on 25 august 2021.The information indicated that there were no visible kinks and no other damages observed on the microcatheter.The stent component of the enterprise device was still on the delivery wire when it was removed from the patient.There was nothing unusual noted on the microcatheter nor on the enterprise device system prior to use.Adequate and continuous flush was maintained through the microcatheter.The reported issue did not result in any procedure delay.The physician completed the procedure using another enterprise system and another prowler select plus microcatheter.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device was received stuck inside the concomitant prowler select plus microcatheter near the tip section.The stent component could not be removed from the microcatheter.The area where it was observed stuck was also noted to be compressed.Dimensional evaluation: the inner diameter (id) of the prowler select plus microcatheter could not be performed due to the condition of the device and with the enterprise stent component stuck inside.The outer diameter (od) of the device was measured: actual microcatheter od (45cm from distal end) = 0.0362 inch; specification: max.0.0375 inch.Actual microcatheter od (5cm from distal end) = 0.0310 inch; specification: max.0.032 inch.Functional analysis: the prowler select plus microcatheter was flushed with warm water in attempt to remove the enterprise stent component from the lumen.However, the stent component could not be removed.The likely contributing factor to the stent being stuck is the observed compressed area noted.The functional test could not be completed with the stent stuck inside the microcatheter.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6253765.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial, the instructions for use (ifu) contains 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.The complaint documented that during an intracranial ischemic procedure with the target position at the middle cerebral artery (mca), the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device could not be advanced nor withdrawn in the 150cm x 5cm, 2 markers prowler select plus microcatheter after the stent arrived in the target position through the microcatheter.Based on the condition of the returned complaint device being stuck inside the lumen of the microcatheter, the reported issue was confirmed.The stent component is likely stuck because the area where it is observed stuck is also one of the compressed areas.The prowler select plus microcatheter has several compressed areas and the enterprise stent was stuck near the tip section where it was also observed to be compressed.The exact cause of the observed compressed areas cannot be conclusively determined.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.H.6: the code ¿no device problem found (c19)¿ was used in the investigation findings because the functional test could not be performed with the stent device stuck inside the concomitant microcatheter.This code corresponds with the ¿cause not established (d15)¿ in the investigation conclusion.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00337.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
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12316816
• Report Number: 3008114965-2021-00336
• Device Sequence Number: 4157894
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 6253765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 09/01/2021; 10/12/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 08/26/2021; 09/01/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM
• Patient Age: 64 YR
• Patient Weight: 85