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

Model Number	PED-500-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Edema (1820); Fistula (1862); Intracranial Hemorrhage (1891)
Date of Event	12/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that post procedure patient experienced right eye edema and it was discovered that carotid cavernous fistula (ccf) occurred due to aneurysm ruptured.The patient was reported a brain death.The patient underwent embolization treatment with flow diversion for a medium size saccular aneurysm located in internal carotid artery in cavernous segment.Maximum diameter of aneurysm: 18.0 mm, neck width of aneurysm: 8.0 mm, blood vessel diameter in landing zone: (distal side ) 4.22 mm, (proximal side) 3.77 mm.The vessel was observed moderately tortuous.Vessel diameter was medium.It was reported that stenosis of the blood vessels in the neck proximal part and the distal part was found but pipeline was safely placed.Eclipse sign after placement was also seen, and the pta was also applied to the stenosis part, although it was in a situation slightly floating but ended.One week later, patient's right eye edema was found, and as a result of angio performed on the (b)(6), it was discovered that ccf occurred due to an burst.Since a large amount of backflow to sov etc.Was seen from cavernous, pao treatment was done.As the flow was found to be reduced, the procedure was temporarily ended.After observation, they would discuss whether to conduct additional treatment.On (b)(6), there was a sudden rise in blood pressure in the morning, and when head ct was performed, broad cerebral infarction was confirmed in the right cerebrum.Cerebral external decompression and internal decompression surgery were performed at the same day.Although high brain swelling was observed, blood flow of m1 was confirmed by doppler.Although a vasopressor was started from the middle of the procedure, it did not improve after the procedure, and the patient became almost clinical brain death state as of (b)(6).Although "coil embolization" was performed in the distal and proximal positions of the pipeline as additional treatment, heart failure, cerebral infarction and complications expanded.The patient became almost clinical brain death state from (b)(6) 2018.
Additional Manufacturer Narrative
Event description - additional information.Date manufacturer received - additional information.Type of report - additional information.Follow-up type - additional information.Additional information, device evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional event information: (b)(6) 2018: the patient was found to have right eye edema.Also, as a result of the angio performed on the 13th, it was discovered that ccf occurred due to aneurysm burst.Since a large amount of backflow to superior ophthalmic vein etc.Was seen from cavernous, parent artery occlusion treatment (previously referred to as "coil embolization") was performed in which multiple coils were placed proximal and distal to the pipeline device.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC NV; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8223351
• Report Number: 2029214-2019-00020
• Device Sequence Number: 16561564
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• 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): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A479933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/04/2019
• 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: Death
• Patient Age: 78 YR