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

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2012

Event Type  malfunction  

Event Description

Citation: briganti et al.Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications a retrospective data analysis.Neuroradiology (2012) 54:1145-1152.Medtronic (covidien) received information through literature review that the authors evaluated two hundred seventy-three patients with 295 cerebral aneurysms, enrolled in 25 centers in italy and treated with the new flow-diverter devices; 142 patients were treated with silk and 130 with pipeline embolization device ped (in one case, both devices were used).The authors reported device deployment failure occurred with 1 patient without any clinical correlation.The author reported that another ped was used after the reported ped deployment failure.No patient injury was reported as result of these procedure.No other detail regarding this event was provided in this article.

Manufacturer Narrative

Article website: http://link.Springer.Com/article/10.1007%2fs00234-012-1047-3.The lot history record review was not possible since the lot number were not reported.The device will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.(b)(4).Serious injury from this article was reported in mdr mfr# 2029214-2015-00252.Death from this article was reported in mdr mfr# 2029214-2015-00253.

• 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
• MDR Report Key: 4606142
• MDR Text Key: 5464773
• Report Number: 2029214-2015-00249
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• 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 Age: 60 YR