MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-400-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The cause of the hemorrhage and mass effect cannot be reliably determined.However, intracranial hemorrhage, mass effect and neurological deficits are a known inherent risk of endovascular procedure and is documented in the pipeline flex instruction for use.
Event or Problem Description
Medtronic received information that this patient's mass effect worsened, approximately 5 weeks post pipeline treatment.It was further reported that this patient developed a subarachnoid hemorrhage (sah) within the pipeline treatment area approximately 5 months post procedure, but the patient was confirmed to have recovered the same day.In addition, visual nerve indication post procedure was noted to have also worsened.The patient received a change in medication.It was further noted that the physician did not believe the sah and mass effect were associated with the procedure nor with the use of the pipeline.Aneurysm treated was located in the paraclinoid segment of the left internal carotid artery.The aneurysm was unruptured, fusiform, size: max diameter 17.0 mm, neck width not measured.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6483711
• Report Number: 2029214-2017-00439
• Device Sequence Number: 1198206
• Product Code: OUT
• UDI-Device Identifier: 00847536015968
• UDI-Public: 00847536015968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2018
• Device Model Number: PED-400-25
• Device Lot Number: A153763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 56