MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-500-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Visual Impairment (2138)
Date of Event	11/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient.Neurological deterioration is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that post the uneventful pipeline embolization procedure of an unruptured 24mm aneurysm, the patient was reported to have neurological deterioration that consisted of ¿mass effect deterioration¿ (4th day post tx.), ocular movement disorder.Approximately, one month later the patient was reported to have mass effect deterioration, headache, vomiting, nausea and ocular movement disorder.2 years post the initial treatment the symptoms of optic nerve were none.The mass effect was unchanged.Mrs two years after the procedure: 2 the aneurysm was in the left internal carotid artery - cavernous / unruptured saccular aneurysm in the cavernous sinus (maximum diameter: 23.9 mm, neck width: 16.2 mm).Past history: smoking in the past, mass effect.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8173879
• Report Number: 2029214-2018-01081
• Device Sequence Number: 13890161
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: PED-500-35
• Device Lot Number: A269298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 69 YR
• Patient Weight: 63