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

Model Number NV UNK PIPELINE

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

Patient Problems Stroke/CVA (1770); Fistula (1862); Hematoma (1884); Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Unspecified Nervous System Problem (4426)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Yangchun li, stephanie h chen, alejandro m spiotta, pascal jabbour, michael r levitt, peter kan, christoph j griessenauer, adam s arthur, joshua w osbun, min s park, nohra chalouhi, ahmad sweid, stacey q wolfe, kyle m fargen, aaron s dumont, travis m dumont,16 marie-christine brunet, samir sur, evan luther, allison strickland, dileep r yavagal, eric c peterson, clemens m schirmer, oded goren, shamsher dalal, gregory weiner, axel rosengart, daniel raper, ching-jen chen, peter amenta, tyler scullen, cory michael kelly, christopher young, michael nahhas, eyad almallouhi, arunprasad gunasekaran, suhas pai, giuseppe lanzino, waleed brinjikji, mehdi abbasi, david dornbos iii, nitin goyal, jeremy peterson, mohammad h el-ghanem, robert m starke.Lower complication rates associated with transradial versus transfemoral flow diverting stent placement.Journal of neurointerventional surgery 31 (2021).Doi:10.1136/neurintsurg-2020-015992.Abstract background currently, there are no large-scale studies in the neurointerventional literature comparing safety between transradial (t ra) and transfemoral (tfa) approaches for flow diversion procedures.This study aims to assess complication rates in a large multicenter registry for tra versus tfa flow diversion.Methods we retrospectively analyzed flow diversion cases for cerebral aneurysms fro m 14 institutions from 2010 to 2019.Pooled analysis of proportions was calculated using weighted analysis with 95%ci to account for results from multiple centers.Access site complication rate and overall complication rate were compared between the two approaches.Results a total of 2,285 patients who underwent flow diversion were analyzed, with 134 (5.86%) treated with tra and 2151 (94.14%) via tfa.The two groups shared similar patient and aneurysm characteristics.Crossover from tra to tfa was documented in 12 (8.63%) patients.There were no access site complications in the tra group.There was a significantly higher access site complication rate in the tfa cohort as compared with tra (2.48%, 95%ci 2.40% to 2.57%, vs 0%;p=0.039).One death resulted from a femoral access site complication.The overall complications rate was also higher in the tfa group (9.02%, 95%ci 8.15% to 9.89%) compared with the tra group (3.73%, 95%ci 3.13% to 4.28%; p=0.035).Conclusion tra may be a safer approach for flow diversion to treat cerebral aneurysms at a wide range of locations.Both access site complication rate and overall complication rate were lower for tra flow diversion compared with tfa in this large series.Reported events.- a complication rate of 8.61% was observed in the total cohort (199 of 2311 patients).This included 53 access site complications, 46 bleeding events (1.99%; subarachnoid hemorrhage, intracerebral hematoma or subdural hematoma), 25 strokes with permanent deficit (1.08%), 47 strokes with temporary deficit or unspecified temporality (2.03%), 11 silent infarcts (0.48%), five new cranial nerve deficits (0.22%), and 29 other complications (1.25%).Access site complications were more common during femoral access, occurring in 53 of 2151 cases (2.48%, 95% ci 2.40% to 2.57%) versus 0 of 134 for radial access (0%, p=0.039).There were four (0.19%) femoral arterial occlusions, 35 (1.63%) superficial hematomas/pseudoaneurysms, 13 (0.60%) retroperitoneal hematomas, and one (0.05%) arteriovenous fistula, with six (0.28%) patients requiring blood transfusion.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11309065
• MDR Text Key: 231205688
• Report Number: 2029214-2021-00164
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• 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): Other; Required Intervention