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 Stenosis (2263)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

Citation: matthew b.Potts, md, maksim shapiro, md, daniel w.Zumofen, md, eytan raz, md, erez nossek, md, keith g.Desousa, md, tibor becske, md, howard a.Riina, md, and peter k.Nelson, md.Parent vessel occlusion after pipeline embolization of cerebral aneurysms of the anterior circulation.J neurosurg january 6, 2017.The device was not returned as it was implanted in the patient; therefore, product analysis of the pipeline devices was not able to be performed.The model and lot numbers of the pipeline embolization devices implanted were not reported in the article.Additional information has been requested from the main author of this article, however no further information has been provided.Should the requested information become available, a supplemental report will be submitted.The pipeline performed as intended as no complications were reported in the literature review.This was a retrospective review of 248 patients that did not have parent vessel occlusion.There was no treatment on the stenosis cases observed, and the reported stenosis resolved upon follow up angiography.Additionally, there was no reported flow limitation, clinical symptoms, or required additional endovascular treatment required.Based on the reported information in the article, there is no evidence suggesting that the device was defective and the in-stent stenosis is most likely related to physiological vascular remodeling; however, the cause of the in-stent stenosis cannot be reliably determined.Other mdrs from this literature review: 2029214-2017-00295, 2029214-2017-00296, 2029214-2017-00297, 2029214-2017-00298, 2029214-2017 -00299, 2029214-2017-00300, 2029214-2017-00301, 2029214-2017-00302, 2029214-2017-00303, 2029214-2017-00304, 2029214-2017-00305, 2029214-2017 -00306, 2029214-2017-00307, 2029214-2017-00308, 2029214-2017-00309, 2029214-2017-00310, 2029214-2017-00311, 2029214-2017-00312, 2029214-2017-00313, 2029214-2017-00314, 2029214-2017-00315, 2029214-2017 -00316, 2029214-2017-00317, 2029214-2017-00318, 2029214-2017-00319, 2029214-2017-00320, 2029214-2017-00321, 2029214-2017-00322, 2029214-2017-00323, 2029214-2017-00324, 2029214-2017-00325, 2029214-2017 -00326, 2029214-2017-00327, 2029214-2017-00328.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through literature review that while evaluating the natural history of in-stent stenosis 1 patient had approximately 70% stenosis at 6 months after pipeline embolization device placement.The observed stenosis was resolved on serial angiography.Progressive in-stent stenosis was documented another patient that had a long dysplastic cavernous / supraclinoid segment aneurysm.This patient was found to have a new focal segment of device related stenosis approximating 60% vessel narrowing at 18 months after embolization.

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 ; 9498373700
• MDR Report Key: 6448747
• MDR Text Key: 71323293
• Report Number: 2029214-2017-00329
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 55 YR