MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 11/21/2022

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.One picture was attached to the complaint file in which can be noted one section of the involved enterprise.A kinked condition was noted in the distal section of the delivery wire.It was noted that the stent was detached inside of the prowler's hub.No other damages can be appreciated.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed based on the detached condition seen in the stent.The customer complaint regarding an impeded condition in the microcatheter was not able to be evaluated since a functional test needs to be performed; the kinked condition noted in the delivery wire may be the result of the impeded condition felt during the procedure however, this investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 803 (and/or part 4, as applicable).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 3008114965-2022-00806 and 3008114965-2022-00807.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, angiographically confirmed the patient suffered from a right ophthalmic artery segment bilateral aneurysm and planned to perform coil embolization of the aneurysm.After vascular access was established, an unspecified coil filled in the aneurysm.It was found that the coil could not maintain an effective shape, then performed stent-assisted coil embolization of the aneurysm.A prowler select plus 150/5cm (606s255x, 30772062) was placed in target position, an enterprise2 4mmx23mm intracranial neurovascular stent (encr402312, 7048258) was advanced within the microcatheter (mc), but the stent was impeded in the middle part of the microcatheter, and it could not advance or withdraw.After several attempts, the delivery wire of the stent was able to withdraw, then the physician retracted the stent to introducer sheath and observed the stent body was released in the microcatheter.A new stent and microcatheter were switched to complete the surgery.There was no patient injury report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that the coil that could not maintain an effective shape was of a competitor¿s brand.No torquing device was used.There was no evidence of physical material within the device.A synchro delivery wire was used successfully with the concomitant device before the encountered issue.There were no procedural delays due the event.As reported by the field, angiographically confirmed the patient suffered from a right ophthalmic artery segment bilateral aneurysm and planned to perform coil embolization of the aneurysm.After vascular access was established, an unspecified coil filled in the aneurysm.It was found that the coil could not maintain an effective shape, then performed stent-assisted coil embolization of the aneurysm.A prowler select plus 150/5cm (606s255x, 30772062) was placed in target position, an enterprise2 4mmx23mm intracranial neurovascular stent (encr402312, 7048258) was advanced within the microcatheter (mc), but the stent was impeded in the middle part of the microcatheter, and it could not advance or withdraw.After several attempts, the delivery wire of the stent was able to withdraw, then the physician retracted the stent to introducer sheath and observed the stent body was released in the microcatheter.A new stent and microcatheter were switched to complete the surgery.There was no patient injury reported.Additional information received indicated that the coil that could not maintain an effective shape was of a competitor¿s brand.No torquing device was used.There was no evidence of physical material within the device.A synchro delivery wire was used successfully with the concomitant device before the encountered issue.There were no procedural delays due the event.One picture was attached to the complaint file in which can be noted one section of the involved enterprise.A kinked condition was noted in the distal section of the delivery wire.It was noted that the stent was detached inside of the prowler's hub.No other damages can be appreciated.A non-sterile enterprise2 4mmx23mm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was observed that the stent was returned detached inside of the involved prowler select plus (606s255x/ 30772062).Also, two kinked conditions were found in the distal portion of the delivery wire.These damages are consistent with the damages seen in the provided picture.The stent was removed from the microcatheter's hub and then inspected under microscopic magnification.It was observed to be undamaged (i.E., no kinks, bents, or broken struts); both ends were found completely flared.The impeded condition, as reported, could not be tested in the lab due to the stent detachment and delivery wire damage; however, the kink noted on the delivery wire section suggests excessive manipulation as a result of the impeded condition.The complaint event documented that the stent was impeded in the middle part of the microcatheter, and it could not advance or withdraw.After several attempts, the delivery wire of the stent was able to withdraw; it is possible that excessive force may have inadvertently been exerted as a result of the stent impeding the microcatheter, causing the delivery wire to become kinked.Consequently, the delivery wire kinking could have resulted in additional manipulation required to remove the enterprise system, resulting in the stent detachment.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure; as such, the customer complaint in relation to the stent becoming impeded in the microcatheter and the premature detachment of the stent in the hub were confirmed.However, with the amount of information available, there is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.A device history record (dhr) of lot number 7048258 was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.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.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).The product has been returned for evaluation and testing.However, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise, which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX23MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15917441
• MDR Text Key: 308159295
• Report Number: 3008114965-2022-00806
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 7048258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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 Sex: Female