MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problem Activation Problem (4042)

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

Event Date 03/13/2022

Event Type  malfunction  

Event Description

As reported by the field, during the use of a 4mmx30mm enterprise intracranial neurovascular stent (encr403012, 6468849), the stent arrived at the tip of the prowler select plus microcatheter (606s255x, 30633471) and the physician tried to release the stent.However, it was observed that the distal marker could not be opened, and the stent body was released about ½.The physician adjusted the stent, but it still failed.Then the physician retracted the stent for inspection, it was found to be released at operation table.The second unspecified stent was used for the surgery, but it was found to be impeded in the microcatheter (mc), so a new microcatheter was changed, the physician completed the surgery successfully.There was no patient injury report.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).Device evaluated by mfr - 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00248.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.Additional information received indicated that the delivery wire of the first enterprise did not snag or get caught on the stent.There was nothing unusual noted about the stent delivery system prior to use.There was no resistance during introduction of the first enterprises through the microcatheter.The second stent was an enterprise stent (encr403012, 6218831).This stent was successfully implanted.There were no surgical delays due to the event.There was no excessive force applied at any time.No other devices were used with the prowler select prior to the event.An adequate flush was maintained through the devices.The concomitant devices functioned as expected.

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: as reported by the field, during the use of a 4mmx30mm enterprise intracranial neurovascular stent (encr403012, 6468849), the stent arrived at the tip of the prowler select plus microcatheter (606s255x, 30633471) and the physician tried to release the stent.However, it was observed that the distal marker could not be opened, and the stent body was released about ½.The physician adjusted the stent, but it still failed.Then the physician retracted the stent for inspection, it was found to be released at the operation table.The second unspecified stent was used for the surgery, but it was found to be impeded in the microcatheter (mc), so a new microcatheter was changed, the physician completed the surgery successfully.There was no patient injury report.Additional information received indicated that the delivery wire of the first enterprise did not snag or get caught on the stent.There was nothing unusual noted about the stent delivery system prior to use.There was no resistance during introduction of the first enterprises through the microcatheter.The second stent was an enterprise stent (encr403012, 6218831).This stent was successfully implanted.There were no surgical delays due to the event.There was no excessive force applied at any time.No other devices were used with the prowler select prior to the event.An adequate flush was maintained through the devices.The concomitant devices functioned as expected.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 6468849.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Partial stent deployment is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device 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.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.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.

Manufacturer Narrative

Product complaint (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.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 the use of a 4mmx30mm enterprise intracranial neurovascular stent (encr403012, 6468849), the stent arrived at the tip of the prowler select plus microcatheter (606s255x, 30633471) and the physician tried to release the stent.However, it was observed that the distal marker could not be opened, and the stent body was released about ½.The physician adjusted the stent, but it still failed.Then the physician retracted the stent for inspection, it was found to be released at the operation table.The second unspecified stent was used for the surgery, but it was found to be impeded in the microcatheter (mc), so a new microcatheter was changed, the physician completed the surgery successfully.There was no patient injury report.Additional information received indicated that the delivery wire of the first enterprise did not snag or get caught on the stent.There was nothing unusual noted about the stent delivery system prior to use.There was no resistance during introduction of the first enterprises through the microcatheter.The second stent was an enterprise stent (encr403012, 6218831).This stent was successfully implanted.There were no surgical delays due to the event.There was no excessive force applied at any time.No other devices were used with the prowler select prior to the event.An adequate flush was maintained through the devices.The concomitant devices functioned as expected.The product was returned to cerenovus for evaluation.Upon arrival, the device was visually inspected, the stent was already detached from the unit, then it was inspected, and no abnormalities were found on it (i.E.No broken struts, no kinks).The introducer and the delivery wire were also inspected, and they were found in good condition.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6468849.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint regarding partial deployment of the stent could not be confirmed since in the inspection of the stent no damages were found on it, the stent was received fully deployed, also no other abnormalities were found on the device that contribute to the complaint.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.A device history record evaluation was performed, and no non-conformances were identified.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: ENTERPRISE2 4MMX30MM
• 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 ; 6465917981
• MDR Report Key: 13965676
• MDR Text Key: 297783899
• Report Number: 3008114965-2022-00247
• 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,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 6468849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/02/2022; 05/19/2022; 06/28/2022
• Supplement Dates FDA Received: 04/26/2022; 05/20/2022; 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• 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: ENTERPRISE2 4MMX30MM; ENTERPRISE2 4MMX30MM; PROWLER SELECT PLUS 150/5CM; UNSPECIFIED STENT