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 Rupture (2208)

Event Date 06/01/2016

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 its cause could not be conclusively determined from the reported information.Petr, o.(2016).Current trends and results of endovascular treatment of unruptured intracranial aneurysms at a single institution in the flow-diverter era.American journal of neuroradiology, 37(6), 1106-1113.Doi:10.3174/ajnr.A4699 mdrs related to this article: 2029214-2016-00627 2029214-2016-00628.

Event Description

Medtronic received information from literature review of complications after pipeline implantation.The purpose of this article was to review the results of endovascular treatment.The 122 patients with 129 aneurysms were treated with flow diverters (124 treated with pipeline embolization device; 5 with another manufacturer's flow diversion device.) of the patients, 104 were female and the mean age was 55.7 years.The mean aneurysm size was 12.3mm it was reported that one patient had post-treatment rupture of a giant left ica aneurysm 11 months after pipeline implantation.It was also reported that another patient underwent partial coiling and pipeline implantation of a left posterior communicating artery aneurysm.The aneurysm ruptured 9.1 months after implantation.

• 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: 5835926
• MDR Text Key: 50813391
• Report Number: 2029214-2016-00627
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• 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: 07/06/2016
• 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