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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2014

Event Type  Death  

Manufacturer Narrative

Bae, h.J., park, y.K., cho, d.Y., choi, j.H., kim, b.S., <(>&<)> shin, y.S.Predictors of the effects of flow diversion in very large and giant aneurysms.Ajnr am j neuroradiol, 42:1099¿1103 (2021).Http://dx.Doi.Org/10.3174/ajnr.A7085.This value is the average age of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Bae, h.J., park, y.K., cho, d.Y., choi, j.H., kim, b.S., <(>&<)> shin, y.S.Predictors of the effects of flow diversion in very large and giant aneurysms.Ajnr am j neuroradiol, 42:1099¿1103 (2021).Http://dx.Doi.Org/10.3174/ajnr.A7085 medtronic literature review found reported of patient complications in association with implantation of pipeline embolization devices to treat cerebral aneurysms.The purpose of this article was to investigate the treatment paradigm for very large and giant aneurysms that has recently changed to flow diversion, in light of the results of the pipeline for uncoilable or failed aneurysms trial.The effects of flow diversion were definitely unknown, and the study explored this topic and identified the predictors of such effects.There were 34 patients in the effect group (66.7%, 34/51; no filling, 35.3%, 18/51; remnant entry, 31.4%, 16/5).The no-effect group comprised 17 patients(33.3%, 17/51; subtotal filling, 29.4%, 15/51; total filling, 3.9% 2/51).The mean age of the effect group was lower than that of the no-effect group (51.2 [sd, 14.9] years versus 57.8 [sd, 12.8] years; p =.126).The mean aneurysm size and neck diameter were 21.9 (sd, 4.3) mm and 10.1 (sd, 4.8) mm, respectively (effect group: 21.4 [sd, 4.1] mm, 9.8 [sd, 4.4] mm; no-effect group: 25.4 [sd, 12.7] mm, 13.2 [sd, 15.4] mm; p =.231, p =.385, respectively).The mean aneurysm size and neck diameters were larger in the no-effect group, but these differences did not reach statistical significance.The effect group was observed in 11/19 (57.8%) aneurysms involving the infraclinoid internal carotid artery, 14/20 (70.0%) aneurysms involving the supraclinoid internal car otid artery, 3/4 (75.0%) aneurysms involving the anterior and middle cerebral arteries, and 6/8 (75.0%) aneurysms involving the vertebrobasilar artery.Among all 51 patients, complications occurred in 7, including 4 deaths (3 delayed ruptures and 1 thromboembolic event) and 3 major c omplications (1 each of rupture, thromboembolic event, and aneurysm mass effect).The overall morbidity and mortality rates were 3.9% (2/51) and 7.8% (4/51), respectively.The article does not state any technical issues during use of the pipeline.The following intra- or post-procedural outcomes were noted: 1.Death of 4 patients (3 delayed ruptures and 1 thromboembolic event) 2.Rupture 3.Thromboembolic event 3.Aneurysm mass effect.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12556750
• MDR Text Key: 274201420
• Report Number: 2029214-2021-01225
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/30/2021
• 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: 55 YR