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

Model Number FA-77350-20

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 09/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pipeline device has not been returned for evaluation.The event could not be confirmed and the cause could not be determined from the reported information.

Event Description

Medtronic received report that a pipeline detached during a flow diversion procedure.The patient had complex anatomy including a complete loop in the distal cervical internal carotid artery (ica).The catheter was navigated past the cervical loop.The physician attempted to place a pipeline device.It was reported that the pipeline fell off unintentionally.The physician withdrew the pipeline without complications.There was no report of patient injury as a result of this event.

Manufacturer Narrative

Additional information: the pipeline braid and the sheath were returned for evaluation without the push wire.Since the pipeline push wire was not returned, the distal and proximal ends of the pipeline braid could not be determined.As received, one end of the braid was fully open with damage and the other end was fully open with no damage.Based on the product analysis findings and the reported event details, the complaint of pipeline detachment could not be confirmed.The pipeline braid was found to be fully open with one end having some damage.The cause for the damage could not be conclusively determined.All braids are 100% inspected for damage, and the braid and protective coil overlap is 100% inspected for irregularities during the manufacturing process.It is possible that the pushwire was inadvertently torqued during procedure subsequently causing the pipeline to deploy during delivery.The ifu (instruction for use) includes a warning "do not torque or pull back wire during insertion.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.¿ other mdrs related to this event: 2029214-2015-05181 2029214-2016-00007.

Event Description

Medtronic received additional event information: the patient was undergoing flow diversion treatment of an unruptured, saccular aneurysm in the right ophthalmic internal carotid artery (ica).Aneurysm measured 14.3mm by 11.3mm with neck width of 7.5mm.Landing zone artery size was 2.46mm distal and 3.61mm proximal.The physician planned to coil the aneurysm and implant a flow diversion device.It was reported that the pipeline detached from the pushwire unintentionally after one rotation.It was reported that the pipeline d etached because the patient's tortuous anatomy did not allow control over deployment.

• Brand Name: PIPELINE 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: 5258376
• MDR Text Key: 32580933
• Report Number: 2029214-2015-05180
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: FA-77350-20
• Device Lot Number: 9851567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• 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: 00058 YR
• Patient Weight: 85