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

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

A lot history record review was not possible since the lot numbers were not reported.The pipeline devices will not be returned for analysis as they were implanted in the patients, therefore the event cause could not be determined.The details of the pipeline migration were not reported and the cause of the event could not be determined based on the reported information.International stroke conference oral abstracts - session title: aneurysm oral abstracts: abstract 8: the pipeline embolization device: midterm results and predictors of outcomes in 335 consecutive patients nohra chalouhi, badih daou, robert m starke, guilherme barros, stavropoula tjoumakaris, robert rosenwasser, david hasan, and pascal jabbour stroke.2016;47:a8, mdrs related to this article: 2029214-2016-00449 2029214-2016-00450.

Event Description

Medtronic received information from literature review that pipeline migration occurred.This study includes 335 patients who underwent pipeline treatment.The mean aneurysm size was 9.4mm.Aneurysms were saccular (84%) and fusiform/dissection (16%).Mean number of pipelines used was 1.2.It was reported that complications occurred, which included pipeline migration (0.5%).

Manufacturer Narrative

Additional information mdrs related to this article: 2029214-2016-00449 2029214-2016-00450 2029214-2017-00189.

Event Description

Medtronic received additional information from review of an article from the same institution and authors.The purpose of the article was to assess the safety and efficacy of the pipeline embolization device, to analyze the effect of operator experience on the complication rate, and to identify predictors of complications and obliteration.The article was a retrospective review of 120 aneurysms in 109 patients treated with the pipeline device.Of the patients, 89 were female and 20 were male; mean age was 57.8 years.The article stated on the six-month follow-up angiogram, one patient with a cavernous aneurysm had delayed proximal migration of the pipeline.The angiogram showed a new jet of contrast against the aneurysm sack.Migration distance was >1cm.There was adequate apposition of the device to the vessel wall after initial deployment.The migration was attributed to the mismatch in atrial diameter between inflow and outflow vessels, which may have produced a constant retrograde squeezing force at the distal end of the device.Subsequently, a second pipeline device was deployed and the aneurysm progressed to complete thrombosis at follow-up.In addition, the article stated that nine patients required balloon angioplasty during implantation of the pipeline device due to inadequate vessel wall apposition and inadequate pipeline expansion.Device deployment was successful in all cases.There were no reports of patient injury in connection with balloon angioplasty.Jabbour, p.Et al (2013).The pipeline embolization device.Neurosurgery, 73(1), 113-120.Doi:10.1227/01.Neu.0000429844.06955.39.

• 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: 5752031
• MDR Text Key: 48307459
• Report Number: 2029214-2016-00450
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• 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