MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problem Activation Failure (3270)

Patient Problem Transient Ischemic Attack (2109)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that a (b)(6) female patient underwent stent-assisted coil embolization of a 3.08mm x 3.2mm (3.3mm neck size) left internal carotid artery (ica) (c6 segment) aneurysm with a 4mm x 23mm enterprise 2 stent (encr402312/6610167) and experienced incomplete stent expansion during the procedure.The stent was semi-released and covered the aneurysm neck; after the aneurysm was embolized with coils, the stent was completely released.However, it was found that the proximal markers of the stent were not completely deployed.It was reported that the intracranial artery was ischemic due to the event.The patient was subsequently given aspirin and clopidogrel.She was then transferred to the intensive care unit (icu) in stable condition.Additional information received indicated that the patient has since been discharged from the hospital.The patient had left ica stenosis of the c5-c6 segments at baseline.Additional information received indicated that the event resulted in cerebral ischemia; the event was diagnosed by the physician.The physician used a microcatheter to massage the stent in an attempt to open/expand the stent.The event did not lead to stent migration or embolization.It is unknown whether the enterprise was patent after the event.The proximal diameter of the parent artery was 2.6mm and the distal diameter of the parent artery was 3.8mm.It was reported that vessel calcification may have contributed to the incomplete stent expansion.The patient does not have any residual symptoms.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.There was no resistance felt during advancement of the device.The stent did not appear to be damaged.There was no evidence of coil protrusion into the parent vessel.No further information was provided.

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was implanted; therefore, no further investigation can be performed.(b)(4) medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6610167.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that a 66-year-old female patient underwent stent-assisted coil embolization of a 3.08mm x 3.2mm (3.3mm neck size) left internal carotid artery (ica) (c6 segment) aneurysm with a 4mm x 23mm enterprise 2 stent ((b)(6)) and experienced incomplete stent expansion during the procedure.The stent was semi-released and covered the aneurysm neck; after the aneurysm was embolized with coils, the stent was completely released.However, it was found that the proximal markers of the stent were not completely deployed.It was reported that the intracranial artery was ischemic due to the event.The patient was subsequently given aspirin and clopidogrel.She was then transferred to the intensive care unit (icu) in stable condition.Additional information received indicated that the patient has since been discharged from the hospital.The patient had left ica stenosis of the c5-c6 segments at baseline.Additional information received indicated that the event resulted in cerebral ischemia; the event was diagnosed by the physician.The physician used a microcatheter to massage the stent in an attempt to open/expand the stent.The event did not lead to stent migration or embolization.It is unknown whether the enterprise was patent after the event.The proximal diameter of the parent artery was 2.6mm and the distal diameter of the parent artery was 3.8mm.It was reported that vessel calcification may have contributed to the incomplete stent expansion.The patient does not have any residual symptoms.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.There was no resistance felt during advancement of the device.The stent did not appear to be damaged.There was no evidence of coil protrusion into the parent vessel.No further information was provided.Returned medical imaging was reviewed by neurointerventionalist, the assessment reads as follows: "the case is supported by video footage which shows a coiled aneurysm in the pcom region with a supporting enterprise stent.The stent is nicely opened in the distal portion but the proximal part of the stent lands too proximal in a perpendicular direction to the arterial wall due to the curve in the internal carotid artery at that point.Several attempts of the physician to open the stent are visible but did not result in proper opening, due to the fact that the laser-cut stent does not foreshorten upon pressure, unlike braided stents.The position of the proximal end of the stent is therefore unchanged, ending into the arterial wall, without possibility to further open up." lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6610167.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Therefore, no corrective action is warranted at this time.Incomplete stent expansion and cerebral ischemia are known potential complications associated with the enterprise 2 vascular reconstruction device (vrd) and are listed in the instructions for use (ifu) as such.With the information provided and without the return of the complaint device, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device selection, and operator technique that may have contributed rather than the design or manufacture of the device.The alleged incomplete stent expansion resulted in cerebral ischemia with the need for medical and surgical intervention (i.E., use of a microcatheter to massage the stent).The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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: ENTERPRISE2 4MMX23MM
• 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 ; 9497898687
• MDR Report Key: 13366422
• MDR Text Key: 288663958
• Report Number: 3008114965-2022-00067
• 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
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6610167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female