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 Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 11/26/2015

Event Type  Death  

Manufacturer Narrative

Daou, b.Et al.(2015).Pipeline embolization device in the treatment of recurrent previously stented cerebral aneurysms.American journal of neuroradiology, 37(5), 849-855.Doi:10.3174/ajnr.A4613 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 defects of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00521 2029214-2017-00522 2029214-2017-00523.

Event Description

Medtronic literature review found reports of patient deaths after pipeline implantation.The purpose of this article was to evaluate the efficacy and safety of the pipeline embolization device (ped) in the treatment of recurrent, previously-stented aneurysms.The authors identified 21 patients with previously-stented recurrent aneurysms who underwent retreatment with ped.These patients were compared with 63 patients who had treatment with the ped without prior stent placement.In the previously-stented group, four patients had an unfavorable outcome (19%) including 1 patient with an mrs of 6 (death).In the ped-only group, one patient experienced a right intracerebral hemorrhage after ped treatment of a right ica aneurysm and died (mrs 6).In addition, the article states that in the ped-only group, seven patients did not have available angiograms; this included three patients who died following the procedure.The causes of death were not provided in the article.Mortality was similar in both the previously-stented and ped-only groups (4.76%).

• 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: 6517580
• MDR Text Key: 73556636
• Report Number: 2029214-2017-00523
• 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): Death