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

Model Number PED-250-20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) off-label use:the pipeline flex device was used to treat an aneurysm in the right anterior cerebral artery (aca) with a pre-existing stent in the deployment area.According to the instruction for use (ifu): the pipeline flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery (ica) from the petrous to the superior hypophyseal segments.Pipeline flex is contraindicated in patients in 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.The pipeline flex involved in this event was implanted in the patient.However, the pipeline flex delivery system was returned and evaluation is still in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.(b)(4).

Event Description

Medtronic (covidien) received report of pipeline flex delivery wire break.The patient was being treated for a small unruptured aneurysm in the right anterior cerebral artery (aca).There was a pre-existing stent in the deployment area.The pipeline flex was advanced and delivered without any resistance.The pipeline flex was deployed without issue.After deployment and upon removal of the microcatheter, it was noted that the delivery system wire had broke just proximal to the resheathing pad.Post-procedure angiographic result showed developing stasis within the aneurysm, as expected.There was no report of patient injury as a result of this event.

Manufacturer Narrative

Device available for evaluation - device evaluated by manufacturer - additional information: the pipeline flex was not returned as it was implanted in the patient; only the pipeline flex push wire was returned for evaluation.As received, push wire was detached from the proximal wire weld.The push wire were sent out for scanning electron microscopy with energy dispersive x-ray spectroscopy analysis (sem-eds).Based on the analysis findings as well as sem-eds analyses, the complaint of pipeline flex push wire fracture was confirmed.It is s uspected that the tensile overload exceeded the strength of the solder joint.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.Off-label use:the pipeline flex device was used to treat an aneurysm in the right anterior cerebral artery (aca) with a pre-existing stent in the deployment area.According to the instruction for use (ifu): the pipeline flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery (ica) from the petrous to the superior hypophyseal segments.Pipeline flex is contraindicated in patients in 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.

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: 5131387
• MDR Text Key: 27703918
• Report Number: 2029214-2015-05031
• 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: Followup,Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2018
• Device Model Number: PED-250-20
• Device Lot Number: A069146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided; 10/15/2015
• Supplement Dates FDA Received: 10/22/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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: 00061 YR