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

Model Number PED-500-35

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

Patient Problems Neurological Deficit/Dysfunction (1982); Visual Impairment (2138)

Event Date 11/19/2016

Event Type  Injury  

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 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 8173879
• MDR Text Key: 130651344
• Report Number: 2029214-2018-01081
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: PED-500-35
• Device Lot Number: A269298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2016
• 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: 69 YR
• Patient Weight: 63