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

Model Number PED-400-18

Device Problems Difficult To Position (1467); Physical Resistance (2578); Activation Failure (3270)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield device has not been returned for evaluation.The reported event could not be confirmed and an event cause could not be conclusively determined from the reported information.It should be noted that the pipeline flex with shield instructions for use (ifu) provide the following precaution: do not place the pipeline flex embolization device with shield technology in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location.Suspect medical device brand name: pipeline flex with shield technology, model number: ped2-400-18.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a pipeline flex with shield did not open during a procedure.The patient was undergoing treatment for a previously-treated aneurysm in the posterior communicating (pcom) artery.Eighteen months prior, the aneurysm had been treated using coils and a stent.The aneurysm max.Diameter was 5mm and neck diameter was 4mm.The landing zone artery size was 3.7mm distal and 3.9mm proximal.Vessel tortuosity was normal.The devices were prepared as indicated in the ifu.A continuous heparinized saline flush was used during the procedure.The aneurysm had recanalized and the patient was undergoing retreatment.It was reported that there difficulty navigating a pipeline flex with shield and microcatheter through the existing stent.At deployment, the pipeline flex did not open in the distal section.The system was removed from the patient.The procedure was completed using coils.There were no reports of patient injury in connection with this event.

Manufacturer Narrative

The pipeline flex with shield was returned for evaluation.As received, the device was within the catheter and was pushed out of the catheter for further examination.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal end of the pipeline braid was found fully open with moderate fraying, while the proximal end was found fully open with no damage.Based on the analysis findings, the report of pipeline flex with shield failure to open at the distal end could not be confirmed.It is possible that the damaged braid may have contributed to the reported issue, however, the cause for damage could not be conclusively determined.In addition, it is possible that the presence of the pre-existing stent may have interfered with proper deployment and function of the pipeline flex with shield device.Additionally, the damage observed on the pipeline braid (fraying) and hypotube (stretching) suggests that excessive force was used during delivery (pushing <(>&<)> pulling).Per our instructions for use (ifu): ¿do not place the pipeline flex embolization device in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location.The presence of other indwelling endovascular stents may interfere with proper deployment and function of the pipeline flex embolization device.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.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿ all products are 100% inspected for damage and irregularities during manufacture.

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: 6419732
• MDR Text Key: 70428150
• Report Number: 2029214-2017-00205
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2019
• Device Model Number: PED-400-18
• Device Lot Number: A275980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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 Age: 68 YR