MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401612

Device Problems Activation Failure (3270); Activation Problem (4042)

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

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The initial reporter phone: (b)(6).The initial reporter email address was not reported.[conclusion]: the healthcare professional reported that during a vascular stent placement procedure to treat a right middle cerebral artery (mca) stenosis, after the balloon catheter was dilated in the target position, the physician initiated the stent implantation using the 4mm x 16mm enterprise 2 vrd (encr401612 / 6424217).The proximal section of the stent was unable to open, the physician used the guidewire to massage the stent but it did not work.A new device was used to complete the procedure.There was no report of any patient adverse event or complication.The product is not available to be returned for evaluation and analysis.The medical imaging included in the complaint underwent independent physician review on (b)(6) 2022.The results of the physician review are documented as follows: ¿the case description has one image attached.The image is a subtracted view with visible markers of an enterprise system and a proximal portion where the markers are not opening and separating.The incomplete opening of a stent such as the enterprise 2 may be secondary to one or multiple factors including but not limited to the following situations.Non opening can be caused by the distal markers being confined by the bend in the artery.Non opening may be the result of vasospasm.In addition, non-opening of a stent may occur if blood is allowed to reflux into the microcatheter before deployment, resulting in coagulated blood products integrating between struts while in the compressed position, which later act as a bond holding the struts together when the stent is released from the microcatheter.The cause of this event cannot be determined solely by the event description and image provided.Further analysis of the complaint enterprise 2, if it becomes available, is recommended to more fully assess for the cause/causes of the above-described failure¿.Physician name and date reviewed: (b)(6) 2022.Based on complaint information, the device is not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6424217.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.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.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 reported that during a vascular stent placement procedure to treat a right middle cerebral artery (mca) stenosis, after the balloon catheter was dilated in the target position, the physician initiated the stent implantation using the 4mm x 16mm enterprise 2 vrd (encr401612 / 6424217).The proximal section of the stent was unable to open, the physician used the guidewire to massage the stent but it did not work.A new device was used to complete the procedure.There was no report of any patient adverse event or complication.The product is not available to be returned for evaluation and analysis.A single medical imaging was returned and forwarded to cerenovus sr.Medical affairs director (neurointerventionalist) for review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 22-jun-2022 and the additional subsequent clarification of information on 23-jun-2022.This mdr submission also includes corrections that were provided in the additional information.[additional information]: on 22-jun-2022, additional information was received.The information indicated that a prowler select plus microcatheter (606s255x / 30593207) was used, the same microcatheter was used to complete the procedure.The stent / stent delivery system did not appear damaged.Nothing unusual was noted on the system prior to use.The information indicated that confirmation was provided from the cerenovus sales representative that ¿after the first stent released in target position, physician found proximal markers could not be opened completely, so implanted a second stent¿ the second stent implanted was a 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412).The reported event did not result in a clinically significant delay in the procedure.The additional information also provided an update/revision to what was originally reported in the complaint.The information indicated that during the procedure targeting a right middle cerebral artery (mca) stenosis, the physician released the 4mm x 16mm enterprise 2 vrd (encr401612 / 6424217) in the target position.Angiography showed that the proximal markers of the stent only opened a little.The physician used the wire to massage the stent, but it did not work.A balloon catheter was dilated in the proximal markers of the stent and the physician implanted a second stent in the target position then completed the procedure.There was no report of any patient adverse event or complication.On 23-jun-2022, additional information was received.The information was provided to add clarification to the information provided on 22-jun-2022.Based on the information, the first stent, 4mm x 16mm enterprise 2 vrd (encr401612 / 6424217) was deployed and implanted in the patient.Angiography showed that the proximal markers of the stent only opened a little.The physician used the wire to massage the stent, but it did not work.A balloon catheter (brand unspecified) was dilated in the area of the proximal markers of the stent and the physician implanted a second stent, a 4.5mm x 14mm enterprise® vascular reconstruction device (enc451412) in the target position then the procedure was completed.Deployment difficulty and incomplete stent expansion requiring additional intervention are known complications associated with the enterprise vascular reconstruction device and are listed in the instructions for use (ifu) as such.If the stent was partially deployed, with vessel wall apposition obtained, and complete deployment was unsuccessful, removal of the stent delivery system/stent could result in dissection, perforation, or other vessel damage.The incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.Since the deployment difficulty and incomplete stent expansion required a second stent to be implanted in order to preclude patient harm, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ corrected section: h.1: type of reportable event: with the additional information, the type of reportable event has been corrected from ¿malfunction¿ to ¿serious injury.¿ h.6: health effect ¿ impact code: with the additional information, the health effect ¿ impact code has been corrected from ¿no health consequences or impact (f26)¿ to ¿surgical intervention (f19).¿ h.6: type of investigation: the additional information indicated that device remains implanted and is not available for return.It was previously reported as ¿device discarded (b18).¿ it has been corrected to ¿device not accessible for testing (b20).¿ updated sections: b.4, d.6a, g.3, g.6, h.1, h.2, h.6, h.10, h.11, and concomitant products.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.H.1: type of reportable event: with the additional information, the type of reportable event has been corrected from ¿malfunction¿ to ¿serious injury.¿ h.6: health effect ¿ impact code: with the additional information, the health effect ¿ impact code has been corrected from ¿no health consequences or impact (f26)¿ to ¿surgical intervention (f19).¿ h.6: type of investigation: the additional information indicated that device remains implanted and is not available for return.It was previously reported as ¿device discarded (b18).¿ it has been corrected to ¿device not accessible for testing (b20).¿.

• Brand Name: ENTERPRISE2 4MMX16MM
• 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: 14474254
• MDR Text Key: 300374061
• Report Number: 3008114965-2022-00325
• 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
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401612
• Device Lot Number: 6424217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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: EU 4.5X14MM STENT 12 MM DW TIP; PROWLER SELECT PLUS 150/5CM