MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Retraction Problem (1536)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - 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 only the stent was shown; this was noted to be already detached from the delivery system, and no damages were able to be seen (i.E., no kinks, bents, or broken struts) both ends were noted completely flared.The rest of the device was not able to be evaluated.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The issue regarding a stent's inability to be recaptured was not able to be evaluated since a functional analysis needs to be performed.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 3008114965-2023-00493.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, during a stent-assist coil embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 7343257) partially released in the patient¿s body.The physician tried to withdraw the stent for adjusting due to the inaccurate positioning.Doctor encountered resistance with the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and the stent could not be retracted.Then, the physician removed the microcatheter and stent from patient¿s body and switched new devices to complete the surgery.The procedure was prolonged about 15 minutes.No patient injury was reported.

Manufacturer Narrative

Product complaint # (b)(4).One picture was attached to the complaint file in which only the stent was shown; this was noted to be already detached from the delivery system, and no damages were able to be seen (i.E., no kinks, bents, or broken struts) both ends were noted completely flared.The rest of the device was not able to be evaluated.The stent detachment was not originally documented in the complaint and the exact time of occurrence cannot be determined.A non-sterile eu 4.5x22mm stent 12 mm dw tip intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that only the detached stent was returned for evaluation.The stent was inspected under magnification and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.A device history record (dhr) was performed and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported regarding the stent's inability to be recaptured was not able to be evaluated since a functional analysis is needed and the stent must still be inside the introducer tube and attached to the delivery wire to perform the functional analysis.The stent detachment was not originally documented in the complaint and the exact time of occurrence cannot be determined.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent defective devices from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following indications and cautions: ¿if stent positioning is not satisfactory, the stent may be recaptured until the point where the proximal end of the stent positioning marker is aligned with the infusion catheter distal marker band (recapturability limit).If stent repositioning is required, gently advance the infusion catheter over the deployed stent (do not pull the stent back into the infusion catheter), reposition the system, and re-deploy the stent in new location.Note: when advancing the infusion catheter over the stent during recapture, it may be necessary to keep the stent stable with tension on the delivery wire.Caution: 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 recapture the stent again.Caution: the stent may be fully recaptured once.Note: be careful to maintain delivery wire access through the detached stent to facilitate access distal to the deployed stent, if necessary.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)(6).Updated sections on this medwatch: b4, b5, g3, g6, h2 and h10.Section b5: additional information received indicated that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The stent had not been deployed beyond the recapurability limit listed in the instructions for use (ifu).The procedure was delays by 15 minutes due to the event.The delay was not clinically significant.Complaint conclusion:as reported by the field, during a stent-assist coil embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 7343257) partially released in the patient¿s body.The physician tried to withdraw the stent for adjusting due to the inaccurate positioning.Doctor encountered resistance with the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and the stent could not be retracted.Then, the physician removed the microcatheter and stent from patient¿s body and switched new devices to complete the surgery.The procedure was prolonged about 15 minutes.No patient injury was reported.Additional information received indicated that they were able to torque the device.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.The stent had not been deployed beyond the recapurability limit listed in the instructions for use (ifu).The procedure was delays by 15 minutes due to the event.The delay was not clinically significant.One picture was attached to the complaint file in which only the stent was shown; this was noted to be already detached from the delivery system, and no damages were able to be seen (i.E., no kinks, bents, or broken struts) both ends were noted completely flared.The rest of the device was not able to be evaluated.The stent detachment was not originally documented in the complaint and the exact time of occurrence cannot be determined.The issue regarding a stent's inability to be recaptured was not able to be evaluated since a functional analysis would be needed would the stent was attached to the delivery wire.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.A device history record (dhr) was performed, and it indicated 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.With the limited evidence available, there is no evidence to suggest that the issue reported in the complaint is related to the device manufacture or design; therefore, no capa activity is required.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 4.5X22MM 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17317845
• MDR Text Key: 319312553
• Report Number: 3008114965-2023-00492
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 7343257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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