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 Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Ischemia (1942); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Loss of Vision (2139); Therapeutic Response, Decreased (2271); Thromboembolism (2654)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Brasiliense lbc, aguilar-salinas p, miller da, tawk rg, sauvageau ea, hanel ra, analysis of predictors and probability of aneurysm occlusion in the ica after treatment with pipeline embolization device, world neurosurgery (2017), doi: 10.1016/j.Wneu.2017.08.099.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 defect of the device during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01193 2029214-2017-01194.

Event Description

Medtronic literature review found reports of adverse events after pipeline implantation.The purpose of this study was to investigate predictors and rate of occlusion for aneurysms along the internal carotid artery (ica).The authors analyzed the results of 83 patients with 117 aneurysms who underwent treatment with the pipeline embolization device (ped); a total of 106 peds were deployed.The patients¿ mean age was 61.2 years; 75 of the patients were female.The article states that major stroke (ischemic or hemorrhagic stroke resulting in mrs 3, 4, or 5) was observed in two patients ((b)(6) female and (b)(6) female): - one patient experienced stroke eight days after ped placement after discontinuing ticagrelor in another facility.The patient subsequently experienced acute occlusion of the ped.The patient was known to be resistant to clopidogrel.The patient reportedly remains severely disabled on latest assessment (mrs of 5).- one patient experienced major stroke five days after ped placement.The patient had undergone ped treatment of a giant, ophthalmic segment aneurysm.Five days after the procedure the patient was found unresponsive at home.Imaging studies revealed a subarachnoid hemorrhage and significant flow inside the aneurysm.The aneurysm was treated with two additional overlapping devices.After two months, the patient had partially recovered, with persistent right hemiparesis, predominantly in the lower limb, and left inferior quadrantanopia (mrs of 3).Angiography performed 10 months after the second treatment showed complete occlusion of the aneurysm.The article also states that one patient ((b)(6) female) experienced neurological death.The article notes the following minor complications: - two patients ((b)(6) female, (b)(6)female) experienced small intracranial hemorrhages after discharge.One of the patients was intact at latest follow-up and the second patient had worsening of double vision (mrs of 2).- two patients ((b)(6) female, (b)(6) female) experienced mass effect after ped treatment: one patient with multiple adjacent aneurysms developed double vision from a partial sixth cranial nerve palsy days after treatment.The symptoms were completely resolved after 7 months.One patient with a giant posterior communicating aneurysm had acute monocular vision loss five days after the ped was placed.Computed tomography showed significant thrombosis of the aneurysm.A second ped was deployed to avoid the risk of aneurysm rupture.The second procedure caused worsening of visual symptoms and the patient was emergently taken to the operating room to decompress the aneurysm and optic apparatus followed by clip ligation of the device and ica, described elsewhere.Five months after surgery the visual symptoms had improved although perception of objects remained limited (mrs of 2).- one patient ((b)(6) female) experienced thromboembolic events, which caused retinal infarcts.The patient recovered with partial loss of central vision (mrs of 1).

• 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: 6986254
• MDR Text Key: 90512139
• Report Number: 2029214-2017-01193
• 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: 10/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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: 10/03/2017
• 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; Required Intervention