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

Model Number	PED-500-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; therefore the report of pipeline flex failure to open on the distal end issue could not be confirmed, and the event cause could not be determined.It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported issue.Per our instructions for use (ifu): 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.Mdrs related to this event: 2029214-2017-00182 2029214-2017-00183.
Event or Problem Description
Medtronic received report that a pipeline flex device did not open on the distal edge during a procedure.The device was resheathed and re-deployed multiple times, which did not resolve the issue.The device was removed and discarded by the customer.There were no reports of patient injury in connection with this event.The patient was undergoing treatment for an unruptured, saccular aneurysm in the left internal carotid artery (ica).The aneurysm max.Diameter was 6mm and neck diameter was 4mm.The distal landing zone was 4.8mm and the proximal landing zone was 5.0mm.The vessel was moderately tortuous.The devices were prepared as indicated in the ifu.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine,ca
• MDR Report Key: 6401597
• Report Number: 2029214-2017-00183
• Device Sequence Number: 35333
• Product Code: OUT
• UDI-Device Identifier: 00847536019638
• UDI-Public: 00847536019638
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: PED-500-14
• Device Lot Number: A313539
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR