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); Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Salem mm, ravindran k, enriquez-marulanda a, et al.Pipeline embolization device versus stent-assisted coiling for intracranial aneurysm treatment: a retrospective propensity score-matched study.Neurosurgery.2020;87(3):516-522.Doi:10.1093/neuros/nyaa041.Medtronic literature review found a report of patient complications in association with a pipeline embolization device (ped).The purpose of this article was to comparatively assess the efficacy of peds and stent-assisted coiling (sac) for treatment of intracranial aneurysms.One hundred seventy peds were used with 135 patients in the study.The median age was 58 (range: 49-65), and 83.5% were female.The article does not state any technical issues during use of the ped.The following intra- or post-procedural outcomes were noted: - 6 patients experienced ischemic complications - 5 patients experienced hemorrhagic complications - 10 instances of retreatment - 6 patients had an mrs score greater than 2 at their last follow-up (on average 11.5 months after the procedure) - 28 patients had incomplete occlusion (<(><<)>90%) of the aneurysm.

• 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: 11025611
• MDR Text Key: 222021079
• Report Number: 2029214-2020-01327
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• 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): Required Intervention
• Patient Age: 58 YR