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

Model Number PIPELINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Occlusion (1984); Vascular Dissection (3160)

Event Date 06/25/2015

Event Type  Injury  

Event Description

Medtronic (covidien) received information from literature review that the following serious adverse events occurred intraprocedural, periprocedural, and during long-term follow up.Intraprocedurally, there were 2 cases of intraluminal thrombus and 1 case of parent vessel occlusion requiring intra-arterial, administration of eptifibatide (180 mg/kg) and deployment of a second ped.There were 4 intraprocedural complication cases in which strokes occurred as a result of acute distal occlusion, secondary to thrombus and branch occlusion.These events occurred in patients under conscious sedation (cs).In 4 patients, cs was converted to general anesthesia (ga) during the procedure after an acute decline in level of consciousness.Periprocedural complications included 4 cerebrovascular accidents (owing to a branch or perforator occlusion), 2 cranial nerve palsies (a third and a sixth nerve palsy in 2 patients with large thrombosed cavernous ica aneurysms), and 1 case of iatrogenic cervical ica dissection that required carotid stent placement.On longer-term follow-up, there were 5 cases of in-stent stenosis requiring angioplasty.The mean duration of follow-up was 6.0 months (range, 3-14.7 months).In this paper, the authors reported the feasibility, safety, and outcomes associated with the use of the ped for intracranial aneurysms performed in awake patients after the administration of conscious sedation (cs) and local anesthetic.Between march 2012 and september 2014, 130 patients with 139 intracranial aneurysm (8 ruptured) were treated with the ped under cs at the authors' institution.During the study period, 130 patients (mean age, 56.16 years; range, 19-82 years; 57 men and 73 women) with 139 aneurysms were successfully treated.Eight of these aneurysms were ruptured and treated in the acute phase.Patients with subarachnoid hemorrhage had a hunt and hess score ranging from i to iii.A total of 155 peds were used in the 139 aneurysms.The mean number of ped deployed for each aneurysm was 1.28 (range, 1-5).During the same procedure, adjunctive coiling was used for the treatment of 23 aneurysms.The main reason for the coils was to obtain prompt aneurysm thrombosis and occlusion.Citation: rangel-castilla l, cress m, munich s, et al.Feasibility, safety, and periprocedural complications of pipeline embolization for intracranial aneurysm treatment under conscious sedation.Operative neurosurgery 0:1-5, 2015.Doi: 10.1227/neu.0000000000000864.

Manufacturer Narrative

Article website: http://journals.Lww.Com/neurosurgery/abstract/publishahead/feasibility,_safety,_and_periprocedural.97675.Aspx.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis, therefore, the event cause could not be determined.There is limited information about the device and/or the patient, therefore all serious adverse events were captured in this report.Reference 2029214-2015-00814 for intraprocedural device problem events from the same article.

• 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: 4943223
• MDR Text Key: 6257341
• Report Number: 2029214-2015-00815
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 56 YR