MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-325-16

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Ischemia (1942); Memory Loss/Impairment (1958); Nausea (1970); Paresis (1998); Dysphasia (2195); Dyskinesia (2363); Convulsion/Seizure (4406); Syncope/Fainting (4411); Unspecified Nervous System Problem (4426)

Event Date 04/18/2021

Event Type  Injury  

Manufacturer Narrative

Report sent in reference to medwatch mw5102232.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline embolization device was implanted into the left paraclinoid with few issues.Post-procedure there were no initial issues, but the patient was admitted to the emergency room at 8:30 am on (b)(6) 2021.The patient could not coordinate the thumb and pinky, and they were diagnosed with a stroke.The patient also experienced a seizure at 6:40 pm and experienced memory issues.The patient returned home with improvement, but then had multiple recurrent strokes.The patient was admitted to the icu with speech and walking difficulties.The physician gave 20 mg/day of dexamethasone, and the vitals were normal.The icu neurologist said the stent was leaching metal into the brain, but also said they were not sure what material would be leaching because there were seven materials in the stent.However the physician stated they had never heard of a stent leaching metal, and declared the other physician was wrong.The patient was discharged from the ica and the steroids were reduced to 18 mg/day with a plan to taper to 6 mg/day.The patient experienced subsequent psychosis and memory-loss.Concomitant medical plavix, aspirin, keppra, dexamethasone, tylenol.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that the patient experienced throwing up 30 days after implant.Patient says after an mri she passes out and unable to use hands.Aneurism is gone.Caller states doctor said something broke off during procedure and metal is leaching into her brain.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12294910
• MDR Text Key: 265621496
• Report Number: 2029214-2021-00991
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015067
• UDI-Public: 00847536015067
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: PED-325-16
• Device Catalogue Number: PED-325-16
• Device Lot Number: A654100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention