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

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

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the reported information, there did not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the cause could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2017-00260 2029214-2017-00261 2029214-2017-00262.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from literature of retreatment after pipeline implantation.The purpose of this article was to evaluate the effect of flow diversion on the patency of the ophthalmic artery when treating ophthalmic artery.The authors retrospectively evaluated 19 patients who underwent pipeline implantation in the treatment of unruptured, ophthalmic artery aneurysms.Of the patients, 16 were female, 3 were male; average age was 53.2 years.Patients underwent follow-up imaging at 6- and 12-months post-implantation.Patients who demonstrated residual aneurysm filling at 6 months were initially asked to stop taking clopidogrel.If the aneurysm still did not thrombose, the patients underwent retreatment at or after 12 months in which an additional pipeline was implanted.The article states that 2 of the 19 patients underwent retreatment.The article states that the two of the pipeline patients experienced ¿major complications¿; no further details were provided on the complications.Durst, c.R.(2015).Endovascular treatment of ophthalmic artery aneurysms: ophthalmic artery patency following flow diversion versus coil embolization.Journal of neurointerventional surgery, 8(9), 919-922.Doi:10.1136/neurintsurg-2015-011887.

• 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: 6441586
• MDR Text Key: 71093649
• Report Number: 2029214-2017-00260
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• 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