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 Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

Citation: adeeb, n.Adeeb, j.M.Moore, c.J.Griessenauer, p.M.Foreman, h.Shallwani, a.A.Dmytriw, h.Shakir, a.H.Siddiqui, e.I.Levy, j.M.Davies, m.R.Harrigan, a.J.Thomas, and c.S.Ogilvy (2017).Treatment of tandem internal carotid artery aneurysms using a single pipeline embolization device: evaluation of safety and efficacy.American journal of neuroradiology.Doi:10.3174/ajnr.A5221.The purpose of this article was to retrospectively analyze consecutive aneurysms treated with the pipeline embolization device (ped) between 2009 and 2016.Cases included aneurysm of the ica treated with a single ped, divided into tandem vs.Solitaire.The solitary group, (median age 58 years) underwent 184 ped procedures for 184 aneurysms.The tandem group, consisting of more than 1 intracranial ica aneurysm within the same anatomic segment or involving adjacent segments (median age 50.5 years) underwent 34 procedures for 78 aneurysms.The authors conclude that tandem aneurysms of the ica can be treated with a single pipeline embolization device with high rates of complete occlusion.There were no mortalities in either group.The cause of the reported events cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the reported complications is related to the embolization procedures and overall patient conditions.Additional information has been requested, however no response has been received.Should the information become available a supplemental report will be submitted.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 of patients treated with the pipeline embolization device (peds), either for solitary or tandem aneurysms, complications were encountered.The complications reported in the study of 268 aneurysms treated with pipelines embolization devices were as follows: retreatment was required in 4.9% of patients treated for solitary aneurysms, and in 5.7% of patients with tandem aneurysms; mrs reportedly worsened in 7% of patients in the solitary aneurysm group; symptomatic thromboembolic complications were encountered in 2.7% solitary aneurysms, and 8.8% tandem aneurysm procedures; symptoms were permanent as a result of ischemic stroke in 1.6% and 2.9% of the procedures respectively; one procedure for treatment of a solitary aneurysm was complicated by both an ischemic stroke and an intraparenchymal hemorrhage.There were no mortalities reported.

• 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: 6773561
• MDR Text Key: 82039802
• Report Number: 2029214-2017-00945
• 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
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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: 07/25/2017
• 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