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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893)

Event Date 10/06/2017

Event Type  Death  

Manufacturer Narrative

Almandoz, j.E., kayan, y., tenreiro, a., wallace, a.N., scholz, j.M., fease, j.L.,.Tenreiro-picón, o.(2017).Clinical and angiographic outcomes in patients with intracranial aneurysms treated with the pipeline embolization device: intra-procedural technical difficulties, major morbidity, and neurological mortality decrease significantly with increased operator experience in device deployment and patient management.Neuroradiology, 59(12), 1291-1299.Doi.Org/10.1007/s00234-017-1930-z the pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defects of the devices during use.The events occurred in the patients post-procedure and its cause could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2018-00220 2029214-2018-00221 2029214-2018-00222 2029214-2018-00223 2029214-2018-00224.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of patient deaths after pipeline implantation.The purpose of this article was to determine whether outcomes after pipeline (ped) treatment improve with operator experience.The authors retrospectively reviewed 140 patients who underwent 150 ped procedures to treat 167 intracranial aneurysms.Of the patients, 109 were women and 31 were men; the mean age was 55.4 years.The article describes the following events: - during a procedure, a ped herniated into the giant ophthalmic ica aneurysm.The ped could not be successfully bridged and the procedure was aborted.The aneurysm subsequently ruptured and the patient experienced fatal subarachnoid hemorrhage pod 0.- one patient experienced fatal post-operative aneurysm re-rupture on pod 14.The patient had undergone ped placement of a ruptured, dissecting a1 segment aneurysm.- one patient experienced fatal contralateral ich on pod 50 due to autopsy-proven amyloid angiopathy and slight p2y12 receptor over- inhibition (pru 58).

• 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: 7366073
• MDR Text Key: 103321012
• Report Number: 2029214-2018-00224
• 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
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 02/27/2018
• 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): Death