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

Model Number FA-71425-30

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Srinivasan, v.M.Et al.(2017).Prolapse of the pipeline embolization device in aneurysms: incidence, management, and outcomes.Neurosurgical focus, 42(6).Doi:10.3171/2017.3.Focus1738 the pipeline device remains implanted in the patient; product analysis cannot be performed.The reported event could not be confirmed; an event cause could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2017-00862 2029214-2017-00863 2029214-2017-00864.

Event Description

Medtronic literature review found a report of pipeline braid foreshortening during placement.The purpose of this article was to determine the incidence of pipeline (ped) foreshortening or migration leading to prolapse as well as to review rescue strategies and outcomes.The authors identified three cases of ped foreshortening leading to prolapse.In case 2, the patient underwent ped implantation in the treatment of a giant right cavernous ica aneurysm (21 x 29 mm, 7.7-mm neck).The patient was symptomatic with symptoms of right-hemisphere ischemia, and had failed previous attempts at a balloon test occlusion (bto) and extracranial-intracranial bypass.The article states that the ped took a tortuous path through the aneurysm and left a short proximal landing zone (3.1 mm).The ped was inadvertently bumped by the microcatheter during recapture of the distal wire; the proximal ped foreshortened and prolapsed into the aneurysm.Distal access was also lost at the same time.Attempts at regaining access, both anterograde, and retrograde through the posterior communicating artery (pcoa), were unsuccessful.A snare was also used in an attempt to pull the distal stent into the aneurysm to allow deployment of a new device, also unsuccessfully.The device was left in situ with the proximal ped in the aneurysm.The patient was maintained on 81 mg of aspirin daily after receiving dual antiplatelet therapy for 1 year.The patient was clinically asymptomatic at the 30-month follow-up, with no change in the aneurysm on follow-up cta.

• 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: 6696944
• MDR Text Key: 79518937
• Report Number: 2029214-2017-00863
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-71425-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR