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

Model Number FA-71500-35

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Natarajan, s.K.Et al.(2016).The safety of pipeline flow diversion in fusiform vertebrobasilar aneurysms: a consecutive case series with longer-term follow-up from a single us center.Journal of neurosurgery, 125(1), 111-119.Doi:10.3171/2015.6.Jns1565 mdrs related to this article: 2029214-2016-00667 2029214-2016-00668 2029214-2016-00669 2029214-2016-00670 2029214-2016-00671 2029214-2016-00672.

Event Description

Medtronic received information from literature review that a patient underwent retreatment after pipeline implantation.The patient initially presented with headache.The patient was found to have a 17mm fusiform aneurysm in the posterior circulation.Three pipeline devices were implanted.There were no technical difficulties noted during the procedure.Seven-months post-procedure, follow-up angiogram showed foreshortening of a pipeline and aneurysm filling.It was not reported which of the three pipeline devices foreshortened.The patient underwent retreatment in which an additional pipeline device was implanted.At the latest angiographic follow up (15 months after the initial procedure), dsa showed no aneurysm remnant and patent pipeline.At the last clinical follow up (17 months after initial procedure), the patient mrs was 0.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5852663
• MDR Text Key: 51340476
• Report Number: 2029214-2016-00669
• 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,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-71500-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• 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): Required Intervention
• Patient Age: 36 YR