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

Model Number PIPELINE

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

Patient Problem Failure of Implant (1924)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Article website: http://journals.Lww.Com/neurosurgery/abstract/publishahead/the_use_of_the_pipeline_embolization_device_in_the.97638.Aspx.The lot history record review was not possible since the lot number was not reported.The device will not be returned for analysis as it was implanted in the patient; therefore, the event cause could not be determined.Other serious adverse events from the same article were reported in mdr# 2029214-2015-00873 and 2029214-2015-00874.

Event Description

Medtronic (covidien) received information from literature review that one patient who was treated with a pipeline embolization device (ped) required placement of a second ped.The saccular posterior communicating artery aneurysm had previously treated with coils prior to the first ped placement.The first ped treatment was performed because 15% of the aneurysm recurred 92 months after coiling.Ten months after the first ped treatment, the patient received a second ped with angiogram result of minimal filling at the neck.Seven months after the last ped procedure the patient had a good clinical outcome with mrs score of 1.The authors' goals was to assess the efficacy and safety of the pipeline embolization device (ped) in the treatment of recurrent previously coiled aneurysms.Thirty-three patients who underwent treatment with the ped of a recurrent previously coiled aneurysm were retrospectively identified.All patients, including those with incomplete aneurysm occlusion, had a significant reduction in aneurysm size.Two aneurysms required another retreatment after ped placement (mdr# 2029214-2015-00872 and 2029214-2015-00873).Ninety-seven percent of patients had a good clinical outcome.Complications were observed in 1 patient (3%), who suffered an intracerebral hemorrhage (mdr #2029214-2015-00874).There were no mortalities.Citation: daou b, starke rm, chalouhi n,et al.The use of the pipeline embolization device in the management of recurrent previously coiled cerebral aneurysms.Neurosurgery.2015 jul 15.Doi: 10.1227/neu.0000000000000901.

• 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 ; 9498373700
• MDR Report Key: 4996648
• MDR Text Key: 22766041
• Report Number: 2029214-2015-00872
• 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,literatur
• Reporter Occupation: Physician
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• 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: 07/22/2015
• 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: 49 YR