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

Model Number PED-325-12

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Thrombosis (2100)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex pushwire was returned for evaluation without the braid as it was implanted in the patient.It was confirmed that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was observed to be bent approximately 32.5cm from the proximal end.The pipeline flex is still undergoing investigation.A follow-up mdr will be submitted when investigation is complete.

Event Description

Medtronic received report of pipeline flex pushwire separation as well as clot formation during a procedure.The patient was undergoing treatment for an unruptured, saccular aneurysm at the left internal carotid artery (ica) terminus.The an eurysm max.Diameter was 14mm and neck diameter was 5mm.Landing zone artery size was 2.80mm distal and 3.23mm proximal.The vessel was minimally tortuous.The devices were prepared as indicated in the ifu.The pipeline flex was deployed.The physician attempted to resheath the device in order to reposition it at which time the pushwire separated at the proximal portion of the resheathing pad.There was reportedly no friction or difficulty when separation occurred.The physician attempted to pull and retrieve the entire system (including the partially deployed device) into the intermediate catheter, but the device deployed into the ica/m1 middle cerebral artery (mca) segment.When deployed, the braid was only partially covering (90%) the aneurysm neck and the proximal section was not fully open.An unsuccessful attempt was made to snare the braid as well as the detached wire (which was inside the braid).Afterward, the snare was used to bump the proximal end of the braid, which fully opened.The broken wire was able to be snared and removed.A new catheter was used to access the neck of the aneurysm and implant coils.Angiography demonstrated possible clot formation along the device.A bolus of reopro was administered followed by iv drip.

Manufacturer Narrative

Additional manufacturer narrative - device evaluation, additional information in regards to the report of pipeline flex failure to open, the event could not be confirmed as the braid was not returned for evaluation; the cause for the braid failure to open could not be conclusively determined from the reported information.In regards to the report of pipeline flex pushwire detachment at the hypotube proximal to the wire weld, the event was confirmed based on gross analysis as well as scanning electron micrographic (sem) / energy dispersive x-ray spectroscopy (eds) analysis.The distal wire was possibly detached due to tensile failure.From the damage observed on the proximal wire (bending) and hypotube (stretching), it is likely that excessive force was applied by the user (pushing and pulling) subsequently causing the solder joint to separate.A review of the manufacturing process did not uncover any deficiencies in regards to the soldering process.Proper soldering technique and surface preparation are well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through sem and eds indicate presence of soldering material, thereby indicating that the soldering was conducted.The lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.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 intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX 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: 5943155
• MDR Text Key: 54445940
• Report Number: 2029214-2016-00801
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2018
• Device Model Number: PED-325-12
• Device Lot Number: A150535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; 10/06/2016
• Supplement Dates FDA Received: 11/01/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 66 YR
• Patient Weight: 108