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

Model Number NV UNK FLEX

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

Patient Problems Visual Disturbances (2140); Stenosis (2263)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c.Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients.Medicine 2021;100:11(e25149) http://d x.Doi.Org/10.1097/md.0000000000025149.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: 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.Refer to manufacturer report 2029214-2021-01108 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c.Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients.Medicine 2021;100:11(e25149) http://d x.Doi.Org/10.1097/md.0000000000025149.Medtronic literature review found reported of patient complications in association with implantation of the flex pipeline embolization device (pled).Wall malapposition was observed in 2 patients.The purpose of this article was to identify patients with, in-stent stenosis (iss) after implantations of pipeline flex embolization devices as treatments for intracranial aneurysms.They observed 5% (6/118) incidence rate of iss in intracranial aneurysmal patients treated with pleds at the institution.The patients were made up of 2 males and 4 females with a mean age of 42.The following intra- or post-procedural outcomes were noted: dizziness.Blurring of vision severe stenosis.Wall malapposition was observed in 2 patients, which occurred in the distal segments of the icas.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 12422423
• MDR Text Key: 273788592
• Report Number: 2029214-2021-01109
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• 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
• Patient Age: 42 YR