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 Occlusion (1984); Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline devices will not be returned for analysis as they were implanted in the patients.The cause of the events could not be conclusively determined from the provided information.Due to the nature of this article, this report may be a duplicate of previously reported adverse events.Pipeline embolization device for treatment of intracranial aneurysms ¿the more, the better? a single-center retrospective observational study.Vol.9, no.2, pp.14¿20.Published october, 2016.Mdrs related to this article: 2029214-2016-01121 2029214-2016-01122.

Event Description

Medtronic received information from literature that some patients experienced complications during or after pipeline implantation.The purpose of this article was to compare midterm occlusion and complication rates in aneurysms treated with a single pipeline embolization device (ped) versus multiple pipeline devices without adjunctive coiling.The authors identified 38 aneurysms in 37 patients; 19 patients with 20 aneurysms were treated with a single ped while 18 patients with 18 aneurysms were treated with two or more peds.31 of the patients were female.Mean age was 53.6 years in the single-ped group and 55.8 years in the multiple-ped group.Retreatment of the target aneurysm was necessary in three cases of the single-ped cases: - in the first retreatment case, retreatment was performed due to aneurysm regrowth.The aneurysm was ruptured and blistered, located in the paraophthalmic internal carotid artery (ica).The aneurysm had increased in size within days after initial single ped placement, recurred early, and transformed into a saccular type.Retreatment was successfully performed in which two additional peds were implanted.At six months, the entire segment including the aneurysm had remodeled - in the second retreatment case, additional ped(s) were implanted because of unchanged angiographic filling and stasis grade (b1) at first and second follow-up dsa performed one year after treatment.- in the third retreatment case, worsening of the stasis grade within days (a3¿a2) was the reason for retreatment.Additional ped(s) were implanted.In-stent thrombosis occurred in two cases.In another case, the pipeline capture coil detached during the procedure.The patient was undergoing treatment for a severe sah from a dissecting p2/3 aneurysm.An attempt was made to reconstruct the artery using multiple peds, but was unsuccessful after detachment of the capture coil in p3.Attempts to retrieve the detached capture coil resulted in a vessel perforation and the artery was instead occluded with coils.The clinical outcome was poor but the authors noted that this was most likely due to severe vasospasm induced by the initial subarachnoid hemorrhage (sah) and resulting in multiple territorial infarctions that were most pronounced in other vascular territories, such as the mca and the contralateral pca-territory.

• 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: 6180828
• MDR Text Key: 62600708
• Report Number: 2029214-2016-01122
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• 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: 11/28/2016
• 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