MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 10/01/2015

Event Type  Death  

Manufacturer Narrative

See related regulatory report 2029214-2020-00244.If information is provided in the future, a supplemental report will be issued.

Event Description

Lv x, jiang c, wu z, jiang w, wang g.Complex cerebral aneurysms: intra-luminal reconstruction using pipeline flow-diverting stent and the obliteration mechanism. the neuroradiology journal.December 2019:1971400919894879.Doi:10.1177/1971400919894879.Medtronic received a report through literature to document the clinical and angiographic outcomes in 80 patients who were treated with the pipeline flow-diverting stent.Forty-five patients were women and 35 were men, with a mean age of 52 years.The study took place between october 2015 and october 2019, 80 patients with 90 complex blood blister¿like, and recurrent side-wall cerebral aneurysms treated with the pipeline were reviewed.Forty-one aneurysms were large or giant, 41 were small, four were recurrent side-wall aneurysms, and four were blood blister¿like aneurysms.In seven patients, a second pfs was necessary to cover the aneurysm neck.Among them, coils were placed in addition to the pfs in 31 aneurysms.82 of 83 aneurysms were occluded for a total occlusion rate of 98.8% there was no patient related morbidity.Mortality occurred in one patient due to thrombolysis from thrombus formation in the left ica, resulting in an ipsilateral remote intraparenchymal hematoma.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9843461
• MDR Text Key: 183769836
• Report Number: 2029214-2020-00245
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2020

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
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/17/2020
• 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): Death
• Patient Age: 52 YR