MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 11/07/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during stent implantation to treat an intracranial stenosis, the physician tried to push the stent component of the 4.5mm x 37mm enterprise® vascular reconstruction device (vrd) (enc453712 / 6451018) out from the introducer but felt resistance.The physician slightly retracted the device to make an adjustment but the delivery wire was broken.Another stent was used to complete the procedure.There was no report any patient adverse event or complication.A photo of the complaint device was provided.On 29-nov-2021, additional information was received.The information indicated that the microcatheter used was a rebar¿ 18 microcatheter (medtronic).It was not necessary to remove the microcatheter when the enterprise stent system was removed.The delivery wire was noted to be separated into two or more pieces.It was reported that the physician was able to move the device even though resistance was encountered.Nothing was noted to be obstructing the device introducer.A continuous flush was maintained through the microcatheter.The information also indicated that the introducer was flushed until liquid was visible at the distal end of the slit in the clear tubing and the tip of the introducer was firmly installed into the hub of the microcatheter hub and locked with the rotating hemostasis valve (rhv) during the attempt to advance it.Excessive force was not applied to the device.Based on the additional information received on 29-nov-2021, the event has been deemed reportable as a "malfunction.".

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.(b)(6).The initial reporter email address is not available / was not reported.(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 photo of the complaint device was provided.The photo was reviewed by the product analysis lab and is documented below.[photo analysis]: based on the photo included in the complaint file, the stent component of the 4.5mm x 37mm enterprise® vrd is observed inside the introducer.No damages can be observed.Only part of the introducer was shown and it could be noted to be without any damages.The delivery wire was not shown in the photo.The reported issue related to the resistance encountered and the damage delivery wire could not be confirmed based on the photo included.(b)(4) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6451018.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Review of the manufacturing record evaluation was performed.The reported issues are not related to the manufacturing process.Further investigation will be performed when the complaint device is returned for evaluation and analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 04-jan-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during stent implantation to treat an intracranial stenosis, the physician tried to push the stent component of the 4.5mm x 37mm enterprise® vascular reconstruction device (vrd) (enc453712 / 6451018) out from the introducer but felt resistance.The physician slightly retracted the device to make an adjustment but the delivery wire was broken.Another stent was used to complete the procedure.There was no report any patient adverse event or complication.A photo of the complaint device was provided.On 29-nov-2021, additional information was received.The information indicated that the microcatheter used was a rebar¿ 18 microcatheter (medtronic).It was not necessary to remove the microcatheter when the enterprise stent system was removed.The delivery wire was noted to be separated into two or more pieces.It was reported that the physician was able to move the device even though resistance was encountered.Nothing was noted to be obstructing the device introducer.A continuous flush was maintained through the microcatheter.The information also indicated that the introducer was flushed until liquid was visible at the distal end of the slit in the clear tubing and the tip of the introducer was firmly installed into the hub of the microcatheter hub and locked with the rotating hemostasis valve (rhv) during the attempt to advance it.Excessive force was not applied to the device.A photo of the complaint device was provided.The photo was reviewed by the product analysis lab and is documented below.[photo analysis]: based on the photo included in the complaint file, the stent component of the 4.5mm x 37mm enterprise® vrd is observed inside the introducer.No damages can be observed.Only part of the introducer was shown and it could be noted to be without any damages.The delivery wire was not shown in the photo.The reported issue related to the resistance encountered and the damage delivery wire could not be confirmed based on the photo included.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6451018.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Review of the manufacturing record evaluation was performed.The reported issues are not related to the manufacturing process.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4.5mm x 37mm enterprise® vrd was received.Visual inspection was performed.It was noted that the delivery wire could be advanced and retracted, the stent component was observed still inside the introducer; this is consistent with the photo included in the complaint; but the stent was not moving with the delivery wire.A microscopic inspection was performed.Under magnification, no damage was observed on the stent component , this is consistent with the photo included in the complaint.There were whitish residues inside the introducer.These residues are presumably residues of dried saline solution.Due to the presence of the residues inside the introducer, the location where the delivery wire and the stent separate could not be discerned.An attempt to flush out / dissolve the whitish residues was not successful.The delivery wire was pulled out of the introducer in one piece; the delivery wire was not broken nor separated into two or more pieces.The delivery wire was detached / separated from the stent component at the stent and delivery wire joint.Functional evaluation could not be performed as the delivery wire was detached / separated from the stent component.The delivery wire was pulled out of the introducer and was observed to be detached / separated at the stent and delivery wire joint.The complaint documented that during the stent implantation targeting an intracranial stenosis, when the physician tried to push the stent component of the complaint device out from the introducer, resistance was felt.The physician slightly retracted the stent to make adjustment, but the delivery wire was broken; through additional information, the delivery wire was reportedly noted to be separated into two or more pieces.The delivery wire was removed from the introducer in one piece.The detachment / separation area was observed at the delivery wire-stent joint.The issue related to the delivery wire being separated into two or more pieces cannot be confirmed.The point of separation was where the delivery wire and the stent is supposed to detach from each other.It was reported that the physician was able to move the device even though resistance was encountered and a continuous flush was maintained through the microcatheter.The issue related to the encountered resistance was not tested as the delivery wire was pulled from the introducer.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance 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.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.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.

• Brand Name: EU 4.5X37MM 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12961970
• MDR Text Key: 285242535
• Report Number: 3008114965-2021-00607
• 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,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: ENC453712
• Device Lot Number: 6451018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REBAR¿ 18 MICROCATHETER (MEDTRONIC)