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

Device Problems Difficult To Position (1467); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

Daou, b.Et al.(2015).Pipeline embolization device in the treatment of recurrent previously stented cerebral aneurysms.American journal of neuroradiology, 37(5), 849-855.The pipeline devices will not be returned for evaluation as they remain implanted in the patients.The devices were not returned, therefore, the events reported in the article could not be confirmed.The causes of the events could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00521, 2029214-2017-00522, 2029214-2017-00523.

Event Description

Medtronic literature review found reports of technical difficulties during pipeline implantation.The purpose of this article was to evaluate the efficacy and safety of the pipeline embolization device (ped) in the treatment of recurrent, previously-stented aneurysms.The authors identified 21 patients with previously-stented recurrent aneurysms who underwent retreatment with ped.These patients were compared with 63 patients who had treatment with the ped without prior stent placement.The article states that in the previously-stented group, the following technical difficulties occurred: in one patient, the distal two-thirds of the ped was deployed with good wall apposition; however, because of prior stent placement, the proximal third did not open and good wall apposition was not achieved.In two patients, there were difficulties in placing the ped across the neck of the aneurysm and achieving appropriate overlap with the previous stent and covering the proximal tines of the stent.The article states that in the ped-only patients, technical difficulties occurred for three patients: in two patients, there were difficulties in opening the proximal part of the ped during deployment.The patients had severe tortuosity of the inflow of the aneurysm.A balloon was used to expand the device.The article did not note any patient injuries in connection with these events.

• 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: 6517575
• MDR Text Key: 73566507
• Report Number: 2029214-2017-00521
• 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
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• 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: 03/28/2017
• 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