MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CX0202

Device Problems Premature Activation (1484); Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.(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.A photo of the complaint device was included in the complaint.The product analysis lab reviewed the photo.The observation is documented below.[photo analysis]: based on the photo, the stent component of the 4.5mm x 28mm no distal tip enterprise® vrd could be noted partially outside of the introducer.No damages were observed on the stent.Only the stent and the hub of one unknown microcatheter could be seen in the photo.No other damages were observed.The reported issue related to resistance during the attempt to deliver the stent could not be evaluated based on the photo.The reported issue related to the premature deployment was confirmed since it was noted that the stent component is partially outside of the introducer.However, the exact time when the stent deployed cannot be conclusively determined.The complaint documented that the stent body was observed to be deformed; this reported issue could not be confirmed based on the photo as there were no damages noted on the stent.(b)(4) performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6451017.The history record indicates this product was final inspection tested at (b)(4) and was determined to be acceptable.Review of the manufacturing record evaluation was performed.The reported issues are not related to the manufacturing process.Further investigation will be performed when the complaint device is returned for evaluation and analysis.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 aneurysm embolization procedure, the physician felt resistance during the attempt to deliver the 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452800 / 6451017) through the microcatheter and observed that the stent component was already released / deployed in the microcatheter.The stent body was observed to be deformed.Another stent was used as a replacement and the procedure was completed.There was no report of any patient adverse event or complication.Photo of the complaint device was included in the complaint.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 09-dec-2021.[additional information]: the healthcare professional reported that during a stent-assisted aneurysm embolization procedure, the physician felt resistance during the attempt to deliver the 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452800 / 6451017) through the microcatheter and observed that the stent component was already released / deployed in the microcatheter.The stent body was observed to be deformed.Another stent was used as a replacement and the procedure was completed.There was no report of any patient adverse event or complication.Photo of the complaint device was included in the complaint.On 09-dec-2021, additional information was received.The information indicated that the patient is a 70-year-old male.The target was a 1.16mm x 8.37mm aneurysm with a neck width of 6.6mm located on the left posterior communicating artery.The microcatheter used was a 150cm x 5cm prowler select plus (606s255x / 30422142).Continuous flush was maintained through the microcatheter.The information indicated that another similar device went through the microcatheter without issue; the specific device was not indicated.There was no damage noted on the microcatheter.The same microcatheter was not used to complete the procedure.When the 4.5mm x 28mm no distal tip enterprise vrd was removed from the patient, the stent component was still on the delivery wire.There was nothing unusual noted about the complaint device prior to use; it was prepped and used as per the instructions for use (ifu).The replacement stent used to complete the procedure was another 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452800).The reported issue did not result in a clinically significant delay in the procedure.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 that the product analysis lab received the complaint device on 04-jan-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, 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.

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 aneurysm embolization procedure, the physician felt resistance during the attempt to deliver the 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452800 / 6451017) through the microcatheter and observed that the stent component was already released / deployed in the microcatheter.The stent body was observed to be deformed.Another stent was used as a replacement and the procedure was completed.There was no report of any patient adverse event or complication.Photo of the complaint device was included in the complaint.On 09-dec-2021, additional information was received.The information indicated that the patient is a 70-year-old male.The target was a 1.16mm x 8.37mm aneurysm with a neck width of 6.6mm located on the left posterior communicating artery.The microcatheter used was a 150cm x 5cm prowler select plus (606s255x / 30422142).Continuous flush was maintained through the microcatheter.The information indicated that another similar device went through the microcatheter without issue; the specific device was not indicated.There was no damage noted on the microcatheter.The same microcatheter was not used to complete the procedure.When the 4.5mm x 28mm no distal tip enterprise vrd was removed from the patient, the stent component was still on the delivery wire.There was nothing unusual noted about the complaint device prior to use; it was prepped and used as per the instructions for use (ifu).The replacement stent used to complete the procedure was another 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452800).The reported issue did not result in a clinically significant delay in the procedure.A photo of the complaint device was included in the complaint.The product analysis lab reviewed the photo.The observation is documented below.[photo analysis]: based on the photo, the stent component of the 4.5mm x 28mm no distal tip enterprise® vrd could be noted partially outside of the introducer.No damages were observed on the stent.Only the stent and the hub of one unknown microcatheter could be seen in the photo.No other damages were observed.The reported issue related to resistance during the attempt to deliver the stent could not be evaluated based on the photo.The reported issue related to the premature deployment was confirmed since it was noted that the stent component is partially outside of the introducer.However, the exact time when the stent deployed cannot be conclusively determined.The complaint documented that the stent body was observed to be deformed; this reported issue could not be confirmed based on the photo as there were no damages noted on the stent.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6451017.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Review of the manufacturing record evaluation was performed.The reported issues are not related to the manufacturing process.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4.5mm x 28mm no distal tip enterprise® vascular reconstruction device was received contained inside a pouch.Visual inspection was performed.The stent was observed halfway out of the introducer.The delivery wire and the introducer were inspected and they were observed to be in good, normal condition.Observations made during the visual inspection of the 4.5mm x 28mm no distal tip enterprise® vrd is consistent with the photo provided in the complaint that showed the stent component partially outside of the introducer.No damages were observed on the delivery wire or the introducer.Microscopic inspection was performed, and one of the stent markers was observed in the middle part of the stent, inside the introducer.When the remaining portion of the stent was pushed out of the introducer, the stent marker was observed to be kinked.Microscopic inspection was performed.The stent component was inspected and under magnification, a stent marker was observed in the middle part of the stent inside the introducer.Functional test could not be performed due to the stent being halfway out of the introducer.The stent component was pushed out from the introducer with significant resistance encountered.A kink at one of the tip markers was observed.Due to the kink observed on the stent marker, the stent was advanced out of the introducer with significant resistance.The resistance encountered during the procedure can be attributed to the damage noted on the stent marker.The premature deployment could be secondary to the resistance and damage present on the stent marker, as excessive manipulation could have inadvertently occurred.Considering the factors previously described the reported issues regarding resistance, premature deployment and deformity were confirmed.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure could be caused by multiple factors, the instructions for use contain the following warnings: 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.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.Updated sections: b.4, g.3, g.6.H.2, 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 ENT4.5MMD 28MML 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12925265
• MDR Text Key: 286586635
• Report Number: 3008114965-2021-00581
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528008894
• UDI-Public: 10878528008894
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2022

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: 06/28/2023
• Device Model Number: 641CX0202
• Device Catalogue Number: ENC452800
• Device Lot Number: 6451017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 01/04/2022; 02/09/2022
• Supplement Dates FDA Received: 12/09/2021; 01/04/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Age: 70 YR
• Patient Sex: Male