MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Cerebral Hyperperfusion Syndrome (4404); Ischemia Stroke (4418)

Event Date 09/09/2021

Event Type  Injury  

Event Description

It was reported that two coil embolization procedures were performed on the patient for aneurysms in two separate locations on two separate dates.There were no complications to the patient following the first procedure.There were no issues encountered in the second procedure that could have contributed to this event.However, post procedure the patient experienced cerebral infarction, hyperperfusion syndrome and allergic reaction.Medication was provided to treat the consequences of this event.The current condition of the patient is unknown.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

H4: manufacturing date added.D4: expiration date added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.No visual or functional inspection was performed due to product was not returned.The risk of the reported event is covered in the device directions for use (dfu).Based upon medical review, the harm observed in the complaint is anticipated in nature as a potential adverse event from these type of procedures and is documented as anticipated as per the device dfu/risk assessment, therefore an assignable cause of 'anticipated procedural complication' was assigned to this complain.

Event Description

It was reported that two coil embolization procedures were performed on the patient for aneurysms in two separate locations on two separate dates.There were no complications to the patient following the first procedure.There were no issues encountered in the second procedure that could have contributed to this event.However, post procedure the patient experienced cerebral infarction, hyperperfusion syndrome and allergic reaction.Medication was provided to treat the consequences of this event.The current condition of the patient is unknown.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13497351
• MDR Text Key: 285327309
• Report Number: 3008881809-2022-00055
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 22021801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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): Other; Required Intervention
• Patient Sex: Female