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

Catalog Number ENCR401612

Device Problems Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter phone: (b)(6).The device was discarded; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, this was a stent assist embolization to a left internal carotid artery communicating segment aneurysm.The patient was placed in the supine position, after general anesthesia was achieved, routine disinfection was performed, a sterile towel was paved on the skin of the inguinal region, a 6f arterial sheath was indwelled after successful puncture of the right femoral artery, and systemic heparinization was performed.At first, total cerebrovascular angiography was performed with a single curve angiography catheter.The left internal carotid artery angiography showed that the size of the left internal carotid artery communicating artery aneurysm was about 2.2 mm × 5.2 mm, the tumor depth was about 5.2 mm, the neck was about 3.0 mm, and the shape was irregular.Under the road map, the 6f guiding catheter was sent to the left internal carotid artery to enter the skull, the operating angle was selected, after the microcatheter was shaped, the microcatheter was sent to the left internal carotid artery communicating segment aneurysm under micro guide wire, the micro guide wire was withdrawn.The micro guide wire was also used to delivery stent microcatheter to the left middle cerebral artery under the road map and micro guide wire was retracted.An enterprise2 4mmx16mm intracranial stent ( encr401612, 6920556) was sent to left middle cerebral artery, but the stent could not be opened during the release process.The physician tried to open the stent again, but still failed.Then doctor retracted stent system and switched to a new stent, slowly released and covered the aneurysm neck, used three coils to embolize the aneurysm densely, reexamined the angiographic aneurysm to complete the embolization, then withdrew the access system, observed the patient's vital signs, and routinely given anti-platelet and other drug treatment.The procedure was completed smoothly, and no patient injury was reported.

Manufacturer Narrative

Product complaint #
=
> (b)(4) updated sections on this medwatch: b4, b5, g3, g6, h2, h6, h10 and concomitant products.Section b5: additional information received indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There had been resistance during advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion (i.E.Tortuosity, calcification, vasospasm).There was no blood flow restriction.The microcatheter used was a id 0.021 in., od 2.4f distal, 2.7f proximal, stryker.The concomitant devices functioned as expected.The same mc was used with the replaced stent.There were no procedural delays due to the event.Complaint conclusion: as reported by the field, this was a stent assist embolization to a left internal carotid artery communicating segment aneurysm.The patient was placed in the supine position, after general anesthesia was achieved, routine disinfection was performed, a sterile towel was paved on the skin of the inguinal region, a 6f arterial sheath was indwelled after successful puncture of the right femoral artery, and systemic heparinization was performed.At first, total cerebrovascular angiography was performed with a single curve angiography catheter.The left internal carotid artery angiography showed that the size of the left internal carotid artery communicating artery aneurysm was about 2.2 mm × 5.2 mm, the tumor depth was about 5.2 mm, the neck was about 3.0 mm, and the shape was irregular.Under the road map, the 6f guiding catheter was sent to the left internal carotid artery to enter the skull, the operating angle was selected, after the microcatheter was shaped, the microcatheter was sent to the left internal carotid artery communicating segment aneurysm under micro guide wire, the micro guide wire was withdrawn.The micro guide wire was also used to delivery stent microcatheter to the left middle cerebral artery under the road map and micro guide wire was retracted.An enterprise2 4mmx16mm intracranial stent ((b)(6)) was sent to left middle cerebral artery, but the stent could not be opened during the release process.The physician tried to open the stent again, but still failed.Then doctor retracted stent system and switched to a new stent, slowly released and covered the aneurysm neck, used three coils to embolize the aneurysm densely, reexamined the angiographic aneurysm to complete the embolization, then withdrew the access system, observed the patient's vital signs, and routinely given anti-platelet and other drug treatment.The procedure was completed smoothly, and no patient injury was reported.Additional information received indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There had been resistance during the advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion (i.E.Tortuosity, calcification, vasospasm).There was no blood flow restriction.The microcatheter used was a id 0.021 in., od 2.4f distal, 2.7f proximal, stryker.The concomitant devices functioned as expected.The same mc was used with the replaced stent.There were no procedural delays due to the event.The device was discarded; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.Resistance/friction with no loss of mc cerebral target position and incomplete expansion of the stent are known potential product failures associated with the use of the device.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16004861
• MDR Text Key: 305942784
• Report Number: 3008114965-2022-00863
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: 6920556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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
• Treatment: .4F DISTAL, 2.7F PROXIMAL, STRYKER MICROCATHETER; 6F GUIDING CATHETER; 6F GUIDING CATHETER; MICRO GUIDEWIRE; MICRO GUIDEWIRE; UNSPECIFIED MICROCATHETER