MAUDE Adverse Event Report: MEDTRONIC PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-500-20
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned as is remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, based on the reported information, operator's technique contributed to the dislodged braid event.Per pipeline flex instruction for use: after the entire pipeline¿ flex embolization device is deployed, advance the micro catheter through the device making sure not to dislodge the braid.Information received from the same report as mdr mfr: 2029214-2016-00127.
Event or Problem Description
Medtronic received information that a pipeline flex was delivered and "jumped" down upon removing the microcatheter and a second pipeline flex did not open during treatment of an aneurysm located in the superior hypophyseal segment of the right internal carotid artery (ica).The aneurysm located just before the bifurcation of the middle cerebral artery (mca) and anterior cerebral artery (aca).The patient had moderate vessel tortuosity and received dual antiplatele treatment prior to procedure.It was reported that the landing vessel was tapered with distal diameter of 3.5mm and the proximal diameter 5.0 mm.The aneurysm max diameter was 10 mm and the neck width was 8 mm.The physician chose the device according to the large part of the proximal vessel.Physician planned to implant a ped-500-20, which was successfully implanted.The physician advanced the microcatheter through the device and captured the delivery wire with the microcatheter and removed it.However, when he removed the mirocatheter the device jumped down to the neck of the aneurysm.The physician then decided to implant another device ped-475-16 to the distal vessel to be able to cover the distal aneurysm neck.The physician passed the first device placed and attempted to deploy the second device however was unable to open the device as the middle distal part of the device did not open.The first landing zone was straight but the mid segment was a curve.The physician opened the device in a straight vessel and then continued to open during a curve.The device was deployed near to resheathing marker but the device stayed like a "sandwich." the physician tried to resheath and re-deploy several times but the device did not open.The device was resheathed within the marksman and removed together from the patient.The physician passed the first device again using another device ped-400-16 and was successfully implanted to the distal part and finish the case successfully.No patient injury was reported.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine CA 92618
• MDR Report Key: 5469856
• Report Number: 2029214-2016-00128
• Device Sequence Number: 11693471
• Product Code: OUT
• Combination Product (Y/N): N
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial
• Report Date (Section B): 02/03/2016

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
• Operator of Device: Physician
• Device Expiration Date: 07/25/2017
• Device Model Number: PED-500-20
• Device Lot Number: 9967350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Initial Report FDA Received Date: 03/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention