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

Catalog Number ENCR402312

Device Problem Activation Failure (3270)

Patient Problems Paralysis (1997); Obstruction/Occlusion (2422); Thromboembolism (2654); Ischemia Stroke (4418); Ruptured Aneurysm (4436)

Event Date 10/27/2022

Event Type  Death  

Event Description

It was reported from the china health authority (nmpa) that a patient underwent an enterprise 2 (catalog encr402312/lot 7115177) stent-assisted endovascular coil embolization of a left posterior communicating artery (pca) aneurysm on 27-oct-2020 but the stent couldn¿t be deployed.It was stated that the patient was admitted to the hospital emergency department due to "about 5 hours of sudden headache".Head computed tomography (ct) showed a subarachnoid hemorrhage, and head computed tomography angiography (cta) showed left pca aneurysm at the beginning portion of this vessel; cerebral vascular examination showed that the aneurysm had a ¿recurrent neck¿ and was irregular aneurysm with a size of about 5.9mm x 6.5mm and a width of 4.5mm.Beside the original embolic aneurysm, a ¿child aneurysm with a size of about 5.9mm * 3.4mm was seen at the front.¿ it was conveyed that during the procedure the stent tip could not be unfolded, and two unsuccessful attempts led to intravascular thrombosis, which blocked the left middle cerebral artery (mca).Thrombolysis with urokinase and tirofiban were not effective and so a solitaire (medtronic) stent was used and was able to remove the thrombus in the lower trunk of the left mca.When preparing to remove the upper trunk thrombus, the angiography showed that the aneurysm had an overflow of contrast agent, which considered another rupture and bleeding, and the arterial thrombectomy was suspended at this time.Physician reportedly used other stent, and this was released to cover the aneurysm neck and tightly embolize the aneurysm ¿ unknown number and brand devices used.Thrombolysis was attempted with of 50 thousand units of urokinase and diluted (1:1) solution of tirofiban and repeatedly injected through micro catheter and guide catheter.However, the clinical effect was poor, resulting in blockage of the upper trunk of left middle cerebral artery and in cerebral infarction.After surgery, the patient was transferred to the icu and continue tirofiban and nimodipine injection intravenously.Now the patient is in a lethargic state, with hemiplegia of the right limb and muscle strength grade 0.

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.Device evaluated by mfr: 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.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.

Manufacturer Narrative

Product complaint # (b)(4).Section b2: date of death: unknown.Section b5: additional information received on 21-dec-2022 indicated that the meanings of the phrase ¿aneurysm had a ¿recurrent neck¿ - ¿child aneurysm" means that there was a recurrence of the aneurysm at the stenosis of the embolized aneurysm; the second phrase means ¿daughter tumor¿.By ¿tirofi¿ they are referring to ¿tirofiban¿.The ¿other stent¿ was an enterprise2 stent, but the catalog and lot number were unknown.The patient passed away.There was no resistance during the advancement of the device and the stent did not appear damaged.It¿s unknown if there were vessel or aneurysm factors that may have contributed to the incomplete expansion.Section h6: health effect - impact code: death was added complaint conclusion: it was reported by the china health authority (nmpa) that a patient underwent an enterprise 2 (catalog encr402312/lot 7115177) stent-assisted endovascular coil embolization of a left posterior communicating artery (pca) aneurysm on (b)(6) 2020 but the stent couldn¿t be deployed.It was stated that the patient was admitted to the hospital emergency department due to "about 5 hours of sudden headache".Head computed tomography (ct) showed a subarachnoid hemorrhage, and head computed tomography angiography (cta) showed a left pca aneurysm at the beginning portion of this vessel; cerebral vascular examination showed that the aneurysm had a ¿recurrent neck¿ and was irregular aneurysm with a size of about 5.9mm x 6.5mm and a width of 4.5mm.Besides the original embolic aneurysm, a ¿child aneurysm with a size of about 5.9mm * 3.4mm was seen at the front.¿ it was conveyed that during the procedure the stent tip could not be unfolded, and two unsuccessful attempts led to intravascular thrombosis, which blocked the left middle cerebral artery (mca).Thrombolysis with urokinase and tirofiban was not effective and so a solitaire (medtronic) stent was used and was able to remove the thrombus in the lower trunk of the left mca.When preparing to remove the upper trunk thrombus, the angiography showed that the aneurysm had an overflow of contrast agent, which was considered another rupture and bleeding, and the arterial thrombectomy was suspended at this time.The physician reportedly used another stent, and this was released to cover the aneurysm neck and tightly embolize the aneurysm ¿ unknown number and brand devices used.Thrombolysis was attempted with of 50 thousand units of urokinase and a diluted (1:1) solution of tirofiban and repeatedly injected through a microcatheter and guide catheter.However, the clinical effect was poor, resulting in blockage of the upper trunk of the left middle cerebral artery and in cerebral infarction.After surgery, the patient was transferred to the icu and continued tirofiban and nimodipine injections intravenously.Now the patient is in a lethargic state, with hemiplegia of the right limb and muscle strength grade 0.Additional information received indicated that the meanings of the phrase ¿aneurysm had a ¿recurrent neck¿ - ¿child aneurysm" means that there was a recurrence of the aneurysm at the stenosis of the embolized aneurysm; the second phrase means ¿daughter tumor¿.By ¿tirofi¿ they are referring to ¿tirofiban¿.The ¿other stent¿ was an enterprise2 stent, but the catalog and lot number were unknown.The patient passed away.There was no resistance during the advancement of the device and the stent did not appear damaged.It¿s unknown if there were vessel or aneurysm factors that may have contributed to the incomplete expansion.A non-sterile enterprise2 4mmx23mm and a non-j&j solitaire stent (medtronic) were received contained in the decontamination pouch.Upon receiving the devices, visual inspection was performed; the enterprise system was found to be in one piece inside the introducer.The stent component was not returned for evaluation.The device was inspected under microscopic magnification and the delivery wire coil was found to be stretched near the distal section of the delivery wire.Some residues of dried saline solution were found along the delivery wire.The damages found on the coiling may have appeared during the two unsuccessful attempts to unfold the stent tip where excessive force may have been inadvertently applied to the device.No other damages or anomalies were found on the device.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 7115177.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer regarding the incomplete expansion of the stent could not be analyzed due to the stent not being returned for evaluation.Cerebral thrombosis, arterial occlusion, cerebral infarction, and aneurysm rupture are known potential adverse events associated with the enterprise 2 vrd and are listed in the instructions for use (ifu) as such.Incomplete stent expansion is also a known potential procedural complication associated with the enterprise 2 vrd.Incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarction.With the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the reported event.Incomplete stent expansion is also a known potential procedural complication associated with the enterprise 2 vrd.Incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarction.With the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the reported event.The incomplete stent expansion required a second stent to be implanted and the investigator felt that the intravascular thrombosis was possibly related to the study device and resulted in additional medical and surgical intervention.In addition, per the additional information received on (b)(6) 2022, the patient expired.Therefore, the event meets mdr reporting criteria as a ¿death¿ with an awareness date of 21-dec-2022.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 events were 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15977486
• MDR Text Key: 305493044
• Report Number: 3008114965-2022-00833
• 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: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 7115177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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: ENTERPRISE2 STENT.; SOITAIRE STENT.; UNSPECIFIED GUIDE CATHETER.; UNSPECIFIED MICROCATHETER.
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female