MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problem Activation Problem (4042)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter phone:(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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a stent assist embolization, a 4.5x12mm eu 12mm dw tip intracranial neurovascular stent (enc451412, 6812665) arrived at target position and released about 2/3 of the stent body.The physician observed that distal markers of the stent were unable to open.The doctor retracted the stent into the 150/5cm prowler select plus microcatheter (606s255x, 30727349) for adjusting and tried to release it again.The distal markers still could not be opened, then tried again, but still failed.The stent was withdrawn with the microcatheter (mc) together outside of the patient¿s body.The physician pushed the stent out for inspection in saline, the markers were unable to open.New devices were switched to complete the surgery.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2, h6 and h10.Section b5: additional information received indicated that there was no alleged product malfunction with the prowler select plus.No additional intervention was needed to remove the device from the patient.No excessive force was applied to the device.There was no resistance encountered prior to the event.An adequate flush was maintained through the devices.There were no procedural delays due to the event.The target vessel/site being treated was the left middle cerebral artery.The diameter of curved blood vessels close to 90 ° is about 2.5mm complaint conclusion: as reported by the field, during a stent assist embolization, a 4.5x12mm eu 12mm dw tip intracranial neurovascular stent (enc451412, 6812665) arrived at target position and released about 2/3 of the stent body.The physician observed that distal markers of the stent were unable to open.The doctor retracted the stent into the 150/5cm prowler select plus microcatheter (606s255x, 30727349) for adjusting and tried to release it again.The distal markers still could not be opened, then tried again, but still failed.The stent was withdrawn with the microcatheter (mc) together outside of the patient¿s body.The physician pushed the stent out for inspection in saline, the markers were unable to open.New devices were switched to complete the surgery.There was no patient injury reported.Additional information received indicated that there was no alleged product malfunction with the prowler select plus.No additional intervention was needed to remove the device from the patient.No excessive force was applied to the device.There was no resistance encountered prior to the event.An adequate flush was maintained through the devices.There were no procedural delays due to the event.The target vessel/site being treated was the left middle cerebral artery.The diameter of curved blood vessels close to 90 ° is about 2.5mm.The device was discarded; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6812665.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Deployment difficulty is a known potential complications that may be associated with the use of the enterprise 2 vascular reconstruction device (vrd) in the intracranial arteries.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.With the information provided and without the return of the device, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.[complaint conclusion updated with device analysis]: as reported by the field, during a stent assist embolization, a 4.5x12mm eu 12mm dw tip intracranial neurovascular stent (enc451412, 6812665) arrived at target position and released about 2/3 of the stent body.The physician observed that distal markers of the stent were unable to open.The doctor retracted the stent into the 150/5cm prowler select plus microcatheter (606s255x, 30727349) for adjusting and tried to release it again.The distal markers still could not be opened, then tried again, but still failed.The stent was withdrawn with the microcatheter (mc) together outside of the patient¿s body.The physician pushed the stent out for inspection in saline, the markers were unable to open.New devices were switched to complete the surgery.There was no patient injury reported.Additional information received indicated that there was no alleged product malfunction with the prowler select plus.No additional intervention was needed to remove the device from the patient.No excessive force was applied to the device.There was no resistance encountered prior to the event.An adequate flush was maintained through the devices.There were no procedural delays due to the event.The target vessel/site being treated was the left middle cerebral artery.The diameter of curved blood vessels close to 90 ° is about 2.5mm.A non-sterile 4.5x12mm eu 12mm dw tip intracranial neurovascular stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the stent was already detached from the unit.No abnormalities were found on it (i.E., no broken struts, no kinks).The delivery wire was inspected, and it was found in good condition.The introducer was not returned for evaluation.The functional analysis could not be performed due to the stent was returned already detached from the unit.The stent must be still inside the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6812665.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Deployment difficulty is a known potential complication that may be associated with the use of the enterprise 2 vascular reconstruction device (vrd) in the intracranial arteries.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Customer complaint regarding the stent not being able to open cannot be tested.Stent component was received outside of the introducer and fully deployed.No contributing factors to the failure mode were identified from the returned device.Is possible that other procedural factors, that cannot be duplicated on the analysis contributed to the reported event.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: EU 4.5X14MM 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14565754
• MDR Text Key: 293727134
• Report Number: 3008114965-2022-00393
• Device Sequence Number: 1
• Product Code: NJE
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

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: 11/28/2023
• Device Catalogue Number: ENC451412
• Device Lot Number: 6812665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 09/19/2022
• Supplement Dates FDA Received: 07/12/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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: 64 YR
• Patient Sex: Female