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

Model Number PED-500-12

Device Problem Activation Failure (3270)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pipeline flex braid was returned for evaluation without the push wire.As received, one end of the pipeline flex was not opened due to damaged braid and the other end was fully opened with damaged braid based on investigation of the event, the report of pipeline flex failure to open at the distal end was confirmed.It is possible that the patient¿s tortuous anatomy may have contributed to the reported issue.Additionally, the damage to the braid is likely the result of the physician resheathing the device more than the recommended two times.All products are 100% inspected for damage and irregularities during manufacture.Per pipeline flex instructions for use (ifu): ¿resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ this event is reported in the following mdrs: 2029214-2015-05220 2029214-2015-05221 2029214-2015-05222.

Event Description

Medtronic received report that a pipeline flex did not open during a procedure.The patient was being treated for a cavernous carotid fistula (ccf).The fistula had been coiled and the physician wanted to implant a pipeline flex to accelerate shut down of the fistula.The vessel was severely tortuous.Landing zone artery size was 4.5mm proximal and distal.A continuous heparinized saline flush was used during the procedure, as per ifu.The pipeline flex was advanced to the treatment site without resistance.Delivery was attempted in a curve of the vessel (genu) and the distal section of the device would not open.The pipeline flex was resheathed four times, which was not successful in opening the device.The device was removed from the patient.Other pipeline flex devices were used to complete the procedure and post-procedure angiographic result showed decreased flow into the fistula.There was no report of patient injury as a result of this event.

• 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: 5325930
• MDR Text Key: 34303669
• Report Number: 2029214-2015-05222
• 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
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2018
• Device Model Number: PED-500-12
• Device Lot Number: A146275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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 Age: 00042 YR
• Patient Weight: 91