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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Infarction, Cerebral (1771); Hemorrhage, Cerebral (1889); Vascular Dissection (3160)

Event Date 01/23/2013

Event Type  Injury  

Event Description

Medtronic (covidien) received information from literature review that serious adverse events after flow diversion treatments with pipeline embolization device performed in 15 patients were reported as follows: one patient experienced right-sided insular intraparenchymal hemorrhage; one patient experienced left basal ganglia infarct; one patient who required balloon angioplasty during the procedure experienced hemiparesis and blurry vision; one patient developed carotid dissection; one patient had ped did not fully expand (40-50%) within the previously placed stent despite balloon angioplasty and the patient's aneurysm remained open at the 3 month follow up.This retrospective study included fifteen patients with recurrent intracranial aneurysms after previous embolization or surgical clipping who were treated with the ped at one institution between 2011 and 2012.Of the 15 patients, 12 were women (80%) and three were men (20%).The mean age of the patients was 54 years (range 31¿80 years).Treatment was successful in all 15 patients.Citation: chalouhi n1, chitale r, starke rm, et al.Treatment of recurrent intracranial aneurysms with the pipeline embolization device.J neurointerv surg.2014 jan;6(1):19-23.Doi: 10.1136/neurintsurg-2012-010612.

Manufacturer Narrative

Article website: http://jnis.Bmj.Com/content/6/1/19.Long off label use: peds were used in patients with pre-existing stent.Per ped ifu contraindications: patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.There is limited information about the device and/or the patient, therefore all serious adverse events were captured in this report.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.Reference mdr 2029214-2015-00521 for device malfunction events from the same article.

• 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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4762977
• MDR Text Key: 5784198
• Report Number: 2029214-2015-00522
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• 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): Required Intervention
• Patient Age: 54 YR