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 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Duckworth, e.A.Et al.(2015).Separating the wheat from the chaff: region of interest combined with metal artifact reduction for completion angiography following cerebral aneurysm treatment.Journal of neurointerventional surgery, 8(11), 1163-1167.(b)(4).The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the information provided in the article, there did not appear to have been any defect of the device during use.The reason for retreatment could not be determined from the information provided in the article.

Event Description

Medtronic literature review found a report of retreatment after pipeline implantation.The purpose of the article was to investigate the investigate different methods of two- and three-dimensional angiography to evaluate the correct positioning of implantable devices while limiting radiation dose to the patient.The authors reviewed 9 patients who underwent 10 procedures; 5 of the patients underwent pipeline implantation to treat cerebral aneurysms.Of the 9 patients, 1 patient had a ruptured aneurysm, 8 aneurysms were in the anterior circulation.Average aneurysm size was 11mm.The article states that two patients treated with the pipeline device were retreated with a second device.

• 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: 6517259
• MDR Text Key: 73557554
• Report Number: 2029214-2017-00507
• 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?: 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: 03/28/2017
• 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
• Patient Outcome(s): Required Intervention