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

Model Number FA-77475-18

Device Problem Flaked (1246)

Patient Problems Infarction, Cerebral (1771); No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2015

Event Type  Injury  

Event Description

Medtronic (covidien) received information that during a flow diversion treatment of an unruptured saccular internal carotid artery (ica) aneurysm using a pipeline embolization device, the physician noticed a coating on the wire had flaked and stripped off in several locations along the length of the wire.The physician loaded the guidewire and the catheter at the same time and reported no resistance encountered when delivering the pipeline.The pipeline was implanted.The pipeline delivery wire was removed from the patient post pipeline deployment as per the ifu.After the wire was removed, the physician inspected the wire and noticed a coating on the wire had flaked and stripped off in several locations along the length of the wire.No damage was found on marksman microcatheter.The physician shaped the wire that was used to thet the marksman in.Angiography post procedure was normal.No patient injury was reported as a result of this procedure.

Manufacturer Narrative

The device will not be returned for evaluation as it was kept by the user facility.Per the customer's photos, the ptfe coating appeared to be damaged at several locations along the pushwire.No other anomalies were observed.No other complaints have been reported against the lot number.The lot history record review of the reported lot number showed no discrepancies that may have contributed to the reported experience.Based on the customer's photo, the customer's report was confirmed.The ptfe coating was damaged.However, the cause for damage could not be determined.All products are 100% inspected for damage and irregularities during manufacture.

Manufacturer Narrative

Received additional information from user facility medwatch.The pipeline was used in an unapproved anatomical location (posterior communicating artery - pcom).Per pipeline flex instruction for use: the pipeline¿ embolization device (ped) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.

Event Description

Additional information from medwatch: female with left-sided pcom aneurysm underwent pipeline embolization.Inspection of the pusher wire after the procedure demonstrated multiple areas of chipping of the hydrophilic coating.After the procedure, the patient was awakened and found to have no new neurologic deficits.She tolerated the procedure well and left the interventional suite in stable condition.A few weeks later the patient was transferred from another hospital with stroke like symptoms.Lesions seen on mri are suspected as being related to chipped hydrophilic material.Patient has been discharged and is currently clinically stable.

• Brand Name: PIPELINE EMBOLIZATIN 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 ; 9498373700
• MDR Report Key: 4726781
• MDR Text Key: 20151238
• Report Number: 2029214-2015-00423
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2016
• Device Model Number: FA-77475-18
• Device Lot Number: 9824980
• Other Device ID Number: 008364620146641611049824980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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): Hospitalization
• Patient Age: 55 YR