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

Catalog Number ENC452212

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The initial reporter phone: (b)(6).[conclusion]: the healthcare professional that angiography confirmed the patient was suffering from severe stenosis of the m1 segment of the left middle cerebral artery (mca).The planned procedure was a stent-assisted angioplasty after balloon dilation.After balloon dilation fully pre-dilated the stenotic vessel, it was observed that vessel could not maintain the effective shape.A 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 / 6920539) was used for dilation.After the microcatheter (unspecified brand) was placed in position, the stent was pushed in the microcatheter.The stent was impeded in the middle part of the microcatheter and could not advance any further.Several unsuccessful attempts to advance the stent were made, then the physician retracted the stent and attempted to re-deliver it to the microcatheter.When the stent arrived at the y connector, the delivery wire broke.A new stent was used to complete the procedure.There was no report of any negative impact to the patient.Additional information related to the procedure and reported device issue is not available.Two photos of the complaint device were included in the complaint.The product analysis lab reviewed the photos; the review is documented below.[photo analysis]: in the photos, the stent component was noted without damage; it was observed deployed and separated from the delivery wire.The time of detachment cannot be determined.One section of the delivery wire is shown in the photos.It can be observed that the delivery wire was separated in to two fragments.The distal fragment of the delivery wire next to the marker band is observed kinked.Based on the photos, the reported issue documented in the complaint that the delivery wire broke was confirmed.The reported issue of the stent being impeded in the microcatheter cannot be determined based on the photos; however, the observed kinked condition on the delivery wire indicates that some force may have been exerted on the device as a result of the reported impeded issue.It is possible that during one of the attempts to advance the stent component, force was inadvertently exerted on the device in effort to advance the stent through the microcatheter, resulting in the delivery wire bending and ultimately breaking off.Clinical and procedural factors including vessel characteristics, device manipulation may have been contributing factor(s) to the reported issue.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6920539.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint device was returned for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.5mm x 22mm enterprise® vrd was received contained in a decontamination pouch.Visual inspection was performed.The stent component was observed in a deployed state and separated from the delivery wire.The delivery wire was observed separated in two fragments as seen in the photos included in the complaint file.No other damages were observed.The stent component underwent microscopic inspection.Under magnification, the stent is noted in good condition without any structural damage (i.E., no broke struts, no kinks nor deformation).The distal fragment of the delivery wire next to the marker band was noted to be kinked.The stent detachment was not originally reported in the complaint and there is no evidence that this issue occurred during the intra operative handling.The stent detachment may have occurred during the post-operative handling of the device and it is not related to the reported issue documented in the complaint.With the evidence available, the issue documented that the delivery wire broke can be confirmed based on the appearance of the returned device.The reported issue of the stent being impeded in the microcatheter could not be tested in the lab due to the stent detachment and delivery wire breakage; however, the kink noted on the delivery wire fragment suggests excessive manipulation as a result of the impeded condition.The complaint event documented that the stent still failed to advance after several attempts, it is possible that excessive force may have inadvertently been exerted on the enterprise system to make the stent pass through the microcatheter, bending the delivery wire to accommodate the stent which ultimately broke off.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.The customer complaint was confirmed.The concomitant microcatheter was not returned for evaluation and additional information related to the concomitant microcatheter used was not provided, no further evaluation could be conducted.However, there is no indication that the issues reported in the complaint are a result from a defect inherently related to the enterprise® vascular reconstruction device.A device history record evaluation was performed, and no non-conformances were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 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 that angiography confirmed the patient was suffering from severe stenosis of the m1 segment of the left middle cerebral artery (mca).The planned procedure was a stent-assisted angioplasty after balloon dilation.After balloon dilation fully pre-dilated the stenotic vessel, it was observed that vessel could not maintain the effective shape.A 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 / 6920539) was used for dilation.After the microcatheter (unspecified brand) was placed in position, the stent was pushed in the microcatheter.The stent was impeded in the middle part of the microcatheter and could not advance any further.Several unsuccessful attempts to advance the stent were made, then the physician retracted the stent and attempted to re-deliver it to the microcatheter.When the stent arrived at the y connector, the delivery wire broke.A new stent was used to complete the procedure.There was no report of any negative impact to the patient.Additional information related to the procedure and reported device issue is not available.On (b)(6) 2022, two photos of the complaint device were included in the complaint file.The photos were reviewed by the product analysis lab.Based on the review, one section of the delivery wire shown in the photo was noted to be separated into two fragments.The photos confirmed the reported issue that the delivery wire broke.The reported event has been deemed reportable as a malfunction.

• 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): 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: 15296571
• MDR Text Key: 305512892
• Report Number: 3008114965-2022-00564
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022

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: 12/28/2023
• Device Catalogue Number: ENC452212
• Device Lot Number: 6920539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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