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

Model Number PED-475-35

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex pushwire and microcatheter were returned for evaluation; however, the pipeline braid was not returned as it was implanted in the patient.The tip coil appeared to be stretched.In addition, the distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was also found to be bent.The microcatheter appeared to be cut and the proximal segment of the catheter along with the hub was not returned.The microcatheter segment returned was noted to be flattened with accordion damage.No other anomalies were observed.Based on the analysis findings we are unable to definitively determine the cause for the reported event.It is possible that the reported moderate vessel tortuosity may have contributed to the resistance during retrieval issue; subsequently causing the pipeline flex delivery system and catheter to become damaged.However, the cause for resistance could not be determined.Additionally, the damages seen on the catheter body (flattening/accordioning), hypotube (stretching), distal and proximal wire (bending); it appears there was excessive force used (pushing and pulling).Per our instructions for use (ifu), the user should discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Furthermore, do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter.Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration.All products are 100% inspected for damage and irregularities during manufacture.Mdrs related to this report: 2029214-2016-01011, 2029214-2016-01012.

Event Description

Medtronic received information that during treatment of an aneurysm located in the left posterior communicating artery, the first device (ped-425-35) landed at the desired location.However during planned percutaneous transluminal angioplasty (pta) the device foreshortened causing the neck to not be fully covered.In order to cover the neck completely, this (ped-475-35) a second device was placed.It was reported that the physician planned to place two pipeline devices.However, upon placing the second pipeline, the same microcatheter was used and the physician was unable to resheath, and the initial pipeline and the second pipeline were apart.The physician made sure the pusher and catheter were able to pass through the pipeline implanted, and tried to advance the guidewire.However, the physician had difficulty removing the pushwire of the pipeline.The physician then decided to cut the microcatheter, a few tenths of a cm from the proximal end, exposed the pusher and attempted removing from the patient but was unable to do so.The physician eventually removed the pusher in tandem with the microcatheter.The second pipeline was not implanted in the intended location and therefore a third pipeline was then implanted between the first two pipelines.The procedure was completed.No patient injury was reported.The aneurysm max diameter was estimated to be 10 mm.The aneurysm neck is unknown.The proximal landing zone was 4.8 mm and the distal landing zone was 4.1 mm.The aneurysm was located in the left internal carotid artery approximately 50 mm proximal of the pcom branch.The patient tortuosity was medium level.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6101210
• MDR Text Key: 59835929
• Report Number: 2029214-2016-01012
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2019
• Device Model Number: PED-475-35
• Device Lot Number: A278736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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): Required Intervention
• Patient Age: 57 YR