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

Model Number NV UNK PIPELINE

Device Problem Migration (4003)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) 2019.Preliminary application of pipeline embolization device in the treatment of large or giant wide-necked aneurysms of the internal carotid artery.Ding wei, huang qiaochun,min qiang, wang mengyang, duan falian.Department of neurosurgery,wuhan first hospital.Information was received regarding a literature article to explore the effect of pipeline on the treatment of large or giant wide-necked aneurysms of the ica.14 patients were included in the clinical trial, clinical efficacy was determined using the modified rankin scale and radiological examination.Of the 15 aneurysms treated, 1 case failed whose pipeline herniated into the lumen of the aneurysm.Immediately after the successful placement of ped,the contrast agent showed obvious retention in the lumen of the aneurysm.Post-operative complications occurred in 2 cases, cranial nerve palsy worsened in 1 case, and thrombic events occurred in 1 case.The mrs was 0 in 12 cases, 1 in 2 cases.At 6 months 13 patients had complete or nearly complete occlusion, and the pipeline which herniated into the lumen of the aneurysm had occlusion, only blepharoptosis was left.No symptoms or neurological deficits were seen at 6 to 21 months.

• 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: 9212492
• MDR Text Key: 168454284
• Report Number: 2029214-2019-01037
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• 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