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 Fistula (1862); Hearing Impairment (1881); Intracranial Hemorrhage (1891)

Event Date 08/21/2014

Event Type  Injury  

Event Description

Citation: tanweer et al.Cavernous carotid aneurysms in the era of flow diversion: a need to revisit treatment paradigms.Am j neuroradiol 35:2334-40.Covidien received information through literature review and the following events were captured as a result of this review: 41 patients with a cavernous carotid aneurysms (cca) were treated with a pipeline embolization device (ped) (mean age 57, 36 females, mean radiographic follow-up was 2 year).(1) an intraoperative ipsilateral subarachnoid hemorrhage was encountered by 1 patient which was likely the result of a wire perforation during an exchange technique to bypass the aneurysm neck.(2) in-stent stenosis 50% was found in 3/43 patients at 6m and an additional case of stenosis was found at 1y.All cases were asymptomatic complete occlusion of the parent vessel along with the aneurysm.(3) three cases of transient neurologic deficits were encountered, 1 of which was a small ipsilateral frontal hematoma at pod3.(4) one case of carotid-cavernous fistula was found on 6m follow-up presenting at pod1 as tinnitus.

Manufacturer Narrative

The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were implanted in the patient; 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.Attempts were made to obtain additional information.(b)(4).Device malfunction from this literature was reported in mfr# 2029214-2015-00120.

• 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: 9775 toledo way; irvine, CA 92618
• MDR Report Key: 4513756
• MDR Text Key: 5441522
• Report Number: 2029214-2015-00120
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR