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 Paresis (1998); Visual Disturbances (2140); Dizziness (2194)

Event Date 02/19/2014

Event Type  Injury  

Event Description

Information received from the article: tan et al.Thromboembolic complications with pipeline embolization device placement: impact of procedure time, number of stents and pre-procedure p2y12 reaction unit (pru) value.J neurointerv surg 2015; 7:217-221.Seventy four patients (mean age 60, 62 females) were treated with pipelines.Two patients experienced hemiparesis.One patient had transient dizziness and double vision.One patient had transient partial vision loss.One patient had transient left hand apraxia and one patient had a delayed intracranial hemorrhage one week after the procedure resulting in left side hemi-neglect.

Manufacturer Narrative

The report was created to capture the post procedure complications received from the article: information received from the article: tan et al.Thromboembolic complications with pipeline embolization device placement: impact of procedure time, number of stents and pre-procedure p2y12 reaction unit (pru) value.J neurointerv surg 2015; 7:217-221.Http://www.Ncbi.Nlm.Nih.Gov/pubmed/24553344.The devices involved in the event will not be returned for evaluation as they were implanted in the patient.The lot history record review was not possible as the lot numbers were not reported.Hemorrhage.(b)(4).

• 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: 4634826
• MDR Text Key: 5594845
• Report Number: 2029214-2015-00291
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/26/2015
• 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): Disability
• Patient Age: 60 YR