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

Model Number FA-77425-12

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

Patient Problems Stroke/CVA (1770); Headache (1880); Unspecified Tissue Injury (4559)

Event Date 03/14/2012

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that patient's aneurysm was implanted with a pipeline embolization device on (b)(6) 2012.The patient was related the next day after one night in the hospital with no complications.Within 2 to 3 weeks after surgery the patient began experiencing excruciating head pain on the right side of their head where the stent was placed.In 2012 the patient's primary care physician ordered an mri and an angiogram which revealed many areas of t2 and flair signal in the right cerebrum which were classified as strokes.No additional treatment was given, and the patient received angiograms every couple years afterwards.Those tests showed that the stent was in place and the aneurysm was occluded.In 2020, the patient consulted with a neurologist for their migraine headaches, and an mri showed active brain lesions which were previously thought to be stroke areas back in 2012.Autoimmune and other diseases were ruled out through a spinal tap and ct scans.The doctor determined that the still active lesions were most likely due to foreign object damage from their surgery, and it was possible material flaked from the stent or catheter during the procedure.The patient continues to be scanned every 6 to 12 months for changes in the lesions.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11625675
• MDR Text Key: 244377022
• Report Number: 2029214-2021-00402
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77425-12
• Device Catalogue Number: FA-77425-12
• Device Lot Number: AU11-030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability