MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

Adeeb n, griessenauer cj, shallwani h, shakir h, foreman pm, moore jm, dmytriw a, gupta r, siddiqui ah, levy ei, snyder k, harrigan mr, ogilvy cs, thomas aj, pipeline embolization device in treatment of 50 unruptured large and giant aneurysms, world neurosurgery (2017), doi:10.1016/j.Wneu.2017.05.128.The pipeline devices will not be returned for evaluation as they remain implanted in the patients; product analysis cannot be performed.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and its cause could not be conclusively determined from the information provided in the article.Mdrs related to this article: 2029214-2017-00931.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of patient complications associated with pipeline implantation.The purpose of this article was to evaluate the safety and efficacy of the pipeline embolization device (ped) in the treatment of large (=20mm) and giant (=25mm) intracranial aneurysms.The authors retrospectively reviewed the results of 50 patients who underwent treatment for 50 large or giant aneurysms.Ped alone was used in 39 of the patients; ped with adjunctive coiling was used in 11 of the patients.Of the patients, 33 were female and 17 were male; the median age was 61.5 years.The article states that the following outcomes occurred: - 8 patients underwent endovascular retreatment - follow-up mrs worsened in 11 patients.(only data for 39/50 patients were available) - thromboembolic complications occurred in 10 patients; 6 of these patients were symptomatic.- hemorrhagic complications occurred in 6 patients; 4 of these patients were symptomatic.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6757587
• MDR Text Key: 81514382
• Report Number: 2029214-2017-00930
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• 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
• Date Manufacturer Received: 07/07/2017
• 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