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

Model Number PIPELINE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aneurysm (1708)

Event Date 12/19/2013

Event Type  Injury  

Manufacturer Narrative

Article website: http://www.Ajnr.Org/content/35/5/948.Long.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.Another serious adverse event from the same article was reported in mdr# 2029214-2015-00913.

Event Description

Medtronic (covidien) received information that one patient experienced a slight upgaze limitation post pipeline embolization device (ped) treatment.The patient presented with visual obscurations and was found to have giant cavernous sinus aneurysm.The patient was treated with 2 peds.Immediately after the procedure, the patient had a delayed, complete cavernous sinus syndrome.At six month follow up the patient had almost complete resolution of these new symptoms but continues to have slight upgaze limitation.In this article, the authors reported rates of occlusion and treatment-related data in 44 patients with cavernous sinus aneurysms treated with flow diversion (ped and other flow diversion devices).Citation: r.C.Puffera, m.Pianoc, g.Lanzino, et al.Treatment of cavernous sinus aneurysms with flow diversion: results in 44 patients.Ajnr am j neuroradiol.2014 may;35(5):948-51.Doi: (b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine ; 9498373700
• MDR Report Key: 5026121
• MDR Text Key: 23908918
• Report Number: 2029214-2015-00913
• 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: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR