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

Catalog Number ENC452212

Device Problems Migration (4003); Activation Problem (4042)

Patient Problem Thromboembolism (2654)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient age, weight, race, ethnicity, and medical history were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.The returned imaging was reviewed by an independent physician on (b)(6) 2020.Image review: ¿accompanying this case complaint is a ppt with imaging from the procedure, both pre-operative cta and intra-operative dsa.The physician reports that the enterprise stent was delivered but was unsure if it fully expanded.The imaging included is all dsa, and it is not possible to see the stent or its markers.There appears to be thrombus formation in the ica in some of the imaging and the left mca does not always opacify in the imaging supplied, suggesting it is occluded.The ica (where the stent was deployed per reports) appears to be large and it is unknown if the stent was appropriate for this size vessel.Having vessel measurements and native (unsubtracted) imaging of the case would be of benefit.¿ physician name and date reviewed: (b)(6).(b)(6) 2020.Incomplete stent expansion, stent migration/embolization, and cerebral thrombosis are known potential complications associated with the enterprise vascular reconstruction device.Per the enterprise instructions for use (ifu), intracranial artery stenting is generally contraindicated in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment due to conditions such as severe intracranial vessel tortuosity, or stenoses, and intracranial vasospasm, not responsive to medical therapy.The ifu also warns the operator to observe stent marker position during coiling procedure to ensure that the stent does not migrate from its deployed position.Assignment of root cause for the event remains speculative and inconclusive based on the information provided, however, it is possible that aneurysm characteristics, vessel tortuosity/spasm, device selection, device interaction, and operator technique may have contributed to the reported event.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 the stent-assisted coil embolization procedure with the target being a ruptured aneurysm on the right internal carotid artery (ica) on the ocular segment where the blood vessels were more tortuous, the physician deployed the 4.5mm x 22mm enterprise® vascular reconstruction device ((b)(4)) at the target location, but ¿only one-mark point could develop in the proximal stent.¿ the physician had intended to release the stent, but he had no idea if it was fully deployed or not.No additional intervention was performed to expand the stent as the physician thought there was no good treatment option.Shortly afterwards, still in the intraoperative stage, the stent spontaneously migrated to the right middle cerebral artery (mca).The procedure was immediately discontinued, and the patient was admitted to the intensive care unit (icu) for monitoring.Digital subtraction angiography (dsa) imaging showed evidence of obstructed blood flow due to the event.It was reported that the patient was discharged from the hospital, but she is not in good health.It is unknown if the event prolonged the patient¿s existing hospital stay.It was reported that vessel tortuosity and vasospasm may have contributed to the incomplete expansion of the stent.It was also reported that interaction with the microcatheter (unknown brand) used for the coil embolization portion of the procedure may have led to the stent migration due to its proximity to the stent.Regarding the device, it was reported that the temperature indicator label on the inner sterile pouch was checked and was observed to be in acceptable criteria.There was no resistance encountered during the advancement of the device; the device did not appear damaged at any time.It was also confirmed that the length of the enterprise stent was at least 10mm longer than the aneurysm neck.Additional event information was provided on 03 september 2020.The information indicated that the patient experienced cerebral thrombosis due to the event.No intervention was performed to address the thrombosis and the event did not result in a stroke.The vasospasm was present at the patient¿s baseline presentation and was not treated.The physician commented that there was ¿no need.Take a rest and the condition will be better.¿ a prowler select plus 150/5cm microcatheter (606s255x / lot# unknown) was used to deliver the enterprise stent.There was no report of any device malfunction or device performance issue related with the prowler select plus microcatheter.Select procedural imaging was provided and will be forwarded to independent physician for review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 19 september 2020.Additional information was provided by the j&j affiliate indicating that no further information can be obtained.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure with the target being a ruptured aneurysm on the right internal carotid artery (ica) on the ocular segment where the blood vessels were more tortuous, the physician deployed the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 11202775) at the target location, but ¿only one-mark point could develop in the proximal stent.¿ the physician had intended to release the stent, but he had no idea if it was fully deployed or not.No additional intervention was performed to expand the stent as the physician thought there was no good treatment option.Shortly afterwards, still in the intraoperative stage, the stent spontaneously migrated to the right middle cerebral artery (mca).The procedure was immediately discontinued, and the patient was admitted to the intensive care unit (icu) for monitoring.Digital subtraction angiography (dsa) imaging showed evidence of obstructed blood flow due to the event.It was reported that the patient was discharged from the hospital, but she is not in good health.It is unknown if the event prolonged the patient¿s existing hospital stay.It was reported that vessel tortuosity and vasospasm may have contributed to the incomplete expansion of the stent.It was also reported that interaction with the microcatheter (unknown brand) used for the coil embolization portion of the procedure may have led to the stent migration due to its proximity to the stent.Regarding the device, it was reported that the temperature indicator label on the inner sterile pouch was checked and was observed to be in acceptable criteria.There was no resistance encountered during the advancement of the device; the device did not appear damaged at any time.It was also confirmed that the length of the enterprise stent was at least 10mm longer than the aneurysm neck.Additional event information was provided on (b)(6) 2020.The information indicated that the patient experienced cerebral thrombosis due to the event.No intervention was performed to address the thrombosis and the event did not result in a stroke.The vasospasm was present at the patient¿s baseline presentation and was not treated.The physician commented that there was ¿no need.Take a rest and the condition will be better.¿ a prowler select plus 150/5cm microcatheter (606s255x / lot# unknown) was used to deliver the enterprise stent.There was no report of any device malfunction or device performance issue related with the prowler select plus microcatheter.Additional event information was provided on 19 september 2020.The information indicated that no further information can be obtained.Select procedural imaging was provided and will be forwarded to independent physician for review.The returned imaging was reviewed by an independent physician on 08 september 2020.Image review: ¿accompanying this case complaint is a ppt with imaging from the procedure, both pre-operative cta and intra-operative dsa.The physician reports that the enterprise stent was delivered but was unsure if it fully expanded.The imaging included is all dsa, and it is not possible to see the stent or its markers.There appears to be thrombus formation in the ica in some of the imaging and the left mca does not always opacify in the imaging supplied, suggesting it is occluded.The ica (where the stent was deployed per reports) appears to be large and it is unknown if the stent was appropriate for this size vessel.Having vessel measurements and native (unsubtracted) imaging of the case would be of benefit.¿ physician name and date reviewed: (b)(6), sept 8, 2020 based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection and packaging of the lot 11202775.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.Incomplete stent expansion, stent migration/embolization, and cerebral thrombosis are known potential complications associated with the enterprise vascular reconstruction device.Per the enterprise instructions for use (ifu), intracranial artery stenting is generally contraindicated in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment due to conditions such as severe intracranial vessel tortuosity or stenoses and intracranial vasospasm not responsive to medical therapy.The ifu also warns the operator to observe stent marker position during coiling procedure to ensure that the stent does not migrate from its deployed position.The device remains implanted and therefore, it is not available for return.Assignment of root cause for the event remains speculative and inconclusive based on the information provided; however, it is possible that aneurysm characteristics, vessel tortuosity / spasm, device selection, device interaction, and operator technique may have contributed to the reported event.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.Updated sections: g.4, g.7, h.2, 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.

• 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
• MDR Report Key: 10536445
• MDR Text Key: 214523796
• Report Number: 3008114965-2020-00381
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: ENC452212
• Device Lot Number: 11202775
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 09/19/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR