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

Model Number FA-71450-35

Device Problems Appropriate Term/Code Not Available (3191); Activation Failure (3270)

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

Event Date 05/28/2015

Event Type  Injury  

Manufacturer Narrative

Kan, p., mokin, m., wakhloo, a., <(>&<)> puri, a.(2015).Techniques in distal access of wide-necked giant intracranial aneurysms during treatment with flow diversion.Surgical neurology international, 6(8), 284.Doi:10.4103/2152-7806.157797 the pipeline device will not be returned for evaluation as it remains implanted in the patient; product analysis cannot be performed.The report of pipeline malapposition and foreshortening could not be confirmed; an event cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00872 2029214-2017-00873.

Event Description

Medtronic literature review found a report of pipeline incomplete opening as well as foreshortening after deployment.The purpose of this article was to present techniques in distal access of wide-necked giant aneurysms through illustrative cases.The article states that in case 3, the patient presented with headache.Mri and catheter angiography demonstrated a 3 × 2-cm giant left cavernous ica aneurysm.The patient subsequently underwent flow diversion treatment.To obtain distal access, a balloon was inflated within the aneurysm.This reduced the volume of the aneurysm to facilitate access to the distal limb of the parent vessel with the looped-around technique.Two peds (4.5 × 35 mm followed by a 4.5 × 20 mm) were deployed across the aneurysm with a 50% overlap.A balloon was then used for angioplasty to address malposition between the first ped and the distal vessel.Upon angioplasty, the two peds became disconnected within the aneurysm and distal access was subsequently lost.On a separate intervention, retrograde access was made to the aneurysm across the anterior communicating artery.Mca access was reestablished, and two additional peds were deployed to connect the disconnected devices.The patient was discharged two days later.The 3-month and 1-year follow-up angiograms showed complete obliteration of the aneurysm.

• 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: 6699760
• MDR Text Key: 79577491
• Report Number: 2029214-2017-00872
• 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
• Type of Report: Initial
• Report Date: 06/15/2017

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-71450-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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): Required Intervention
• Patient Age: 58 YR