MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.00MM X 12MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-12

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause was unknown.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

Medtronic received information that this patient was treated with pipeline and is reporting to have permanent brain damage.It was reported that after placement she had vasculitis and neuro symptoms and was discharged within 24 hours of the procedure with no follow up mri/mra.The patient was reported to be back in the er within 18hours with symptoms of a brain injury.

Manufacturer Narrative

Patient mdrs related to this report: 2029214-2017-00019.

Event Description

Medtronic received additional information from the treating physician.It was reported by the treating physician, that the patient was never diagnosed with vasculitis.It was further reported that during the procedure, there was some routine catheter induced vasospasm in the left internal carotid artery that was treated with verapamil without incident.On the final angio control images after placement of the pipeline, there was noted to be some regions of vessel narrowing and dilation in the distal left anterior cerebral artery, which was notably far from the location of the pipeline.At the time, it was unclear if this narrowing was artifact from segments of vessel dilation (from the verapamil) or related to real arteriopathy/vasculitis.The physician indicated that the pipeline was not likely to have caused vasculitis as it is an inflammatory condition and would not occur immediately (or within minutes of pipeline placement) and would not be seen as vessel dilation in this acute setting.The patient woke up from anesthesia without any significant neurological changes from her baseline.Cta of the head one day post procedure was negative/normal.Mri/mra of the brain was performed on (b)(6) 2015 (approximately 2 months post op) was also negative/normal.Although there was no evidence of vasculitis/vascular dementia an mri/mra was ordered to evaluate.On (b)(6) 2015, the patient was evaluated by a neurologist who concluded that this patient did not have vasculitis.On (b)(6) 2015, the patient had a catheter diagnostic cerebral angiogram for follow-up which was also negative for vasculitis.

Manufacturer Narrative

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

Medtronic received additional information from a voluntary event report, medwatch report number mw5067886.The patient reports experiencing neurological symptoms such as "confusion, temporary mutism, writing intelligible words, agitation, retrograde amnesia" after pipeline implantation.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX 4.00MM X 12MM
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6207548
• MDR Text Key: 63357679
• Report Number: 2029214-2016-01137
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-400-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Disability
• Patient Age: 53 YR
• Patient Weight: 76