MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX39MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF403900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/29/2018

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Date of death is not known.Date of event: the event occurred in 2019, however, the date of the event was not reported.The product catalog and lot numbers are not available / not reported.The expiration date of the device is not known.The device manufacture date is not known as the product lot number of the device is not available / not reported.The enterprise® vascular reconstruction device is intended for use with occlusive devices in the treatment of intracranial aneurysms.Death is a known potential adverse event associated with the device.Based on the information provided, the cause of death could not be determined; however, death due to unknown cause and occurred during a procedure using our device, it meets mdr reporting as a death.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 a patient was admitted for a procedure to have the enterprise stent (catalog/lot numbers not available) placed for unspecified reason.It was reported that the patient expired during the procedure.The cause of death was not provided but it was reported that the death was not related to the enterprise device.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 2/7/2019, related to the death event reported.It was reported that the procedure was successful, but the infarct had been too advanced, and the patient expired during the procedure due to results of the infarction.According to the physician, the death was not related to the enterprise stent as there was no malfunction related to the device.Based on the additional information received, the event no longer meets the required criteria for medical device reporting.[conclusion]: the healthcare professional reported that the patient presented with a complete occlusion of the left vertebral artery at the level of c2 vertebra consistent with arterial dissection as well as basilar artery occlusion.The target vessels were the vertebral and basilar artery occlusions; there was no aneurysm present.The 4 mm x 39 mm enterprise®2 (enf403900 / 10952024) was used to treat the occlusion and was successfully deployed and implanted in the right vertebral artery extending distal to the origin of the right posterior inferior cerebellar artery and up to the origin of the left posterior cerebral artery.Reperfusion of the distal right vertebral artery and basilar artery was achieved after the stent placement with tici 2b reperfusion score.The patient had also been given intravenous integrilin bolus of 180mcg/kg followed by continuous infusion at 2mcg/kg/min.There was no evidence of device malfunction or procedure complication.It was reported that the procedure was successful, but the infarct had been too advanced, and the patient expired during the procedure due to results of the infarction.According to the physician, the death was not related to the enterprise stent.The enterprise® vascular reconstruction device is intended for use with occlusive devices in the treatment of intracranial aneurysms.Information was forwarded to the cerenovus complaint handling unit as a routine off-label use report, not as a death complaint.Death is a known potential adverse event associated with the device; however, the patient had presented with acute thrombotic infarction of the basilar artery and left vertebral artery dissection.The enterprise stent was successfully used off-label to open the vessel; however, due to the pre-existing stroke, the patient expired.The death was not related to the enterprise stent; therefore, the death is a non-product issue.Lake region medical performed the review of the device history records (dhr) relative to the manufacturing, inspecting and packaging of the lot 10952024.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported death event was not associated to the procedure or to the enterprise device.Therefore, it has been deemed not reportable.No further reports will be forthcoming.

• Brand Name: ENTERPRISE2 4MMX39MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 325 paramount dr; raynham, MA 02767 ; 949789-868
• MDR Report Key: 8287236
• MDR Text Key: 134410572
• Report Number: 1226348-2019-00824
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: ENF403900
• Device Lot Number: 10952024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 16 YR
• Patient Weight: 61