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

Model Number PIPELINE

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2011

Event Type  malfunction  

Event Description

Citation: lubicz et al.Pipeline flow-diverter stent for endovascular treatment of intracranial aneurysms: preliminary experience in 20 patients with 27 aneurysms.World neurosurgery (2011) 76, 1/2:114-119.Medtronic (covidien) received information through literature review that there were technical issues in pipeline delivery including stent migration, stent misplacement, unanticipated stent shortening, and the impossibility to recapture the distal coil tip of the supporting device.It was reported that the author study a population of 20 patients (mean age 49, 14 females) with 27 fusiform or wide-necked aneurysms that were treated with pipeline embolization device (ped).Tha author reported that in 7 out of 27 cases the coil tip remained stuck at the distal tip of the delivery catheter and could not be resheathed despite the use of a dedicated torque.No stent dislodgment occurred during these manipulations.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

(b)(4).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.The authors stated that the stent shortening and migration may happen due to inappropriate device size and length selection because they "always choose a stent diameter 0.25-0.5mm larger than the distal parent artery diameter and longer length to ensure good stability." the instruction for use indicated, "select an appropriately sized ped such that it is fully expanded diameter is equivalent to that of the largest target vessel diameter.An incorrectly sized ped may result in inadequate device placement, incomplete opening, or distal migration." (b)(4).Death from the same article was reported in mdr mfr# 2029214-2015-00241.

• 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: 4587747
• MDR Text Key: 5335966
• Report Number: 2029214-2015-00241
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Device Catalogue Number: PIPELINE
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• 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: 49 YR