MAUDE Adverse Event Report: MEDTRONIC PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Intracranial Hemorrhage (1891); Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Li w, tian z, zhu w, et al.Hemodynamic analysis of postoperative rupture of unruptured intracranial aneurysms after placement of flow-diverting stents: a matched case-control study. ajnr american journal of neuroradiology.2019;40(11):1916-1923.Doi:10.3174/ajnr.A6256.Medtronic literature review found reports of postoperative rupture of intracranial aneurysm after pipeline placement.The authors reviewed ten patients with postoperative aneurysm rupture, and twenty patients without postoperative aneurysm rupture.Patient demographic information was not provided.The study took place between 2014 and 2018.The article states that twelve patients experienced unexpected aneurysm subarachnoid hemorrhage complications, and 3 patients had unstable flow after ped treatment.It was noted that there was mortality as a complication related to intracranial hemorrhage, but no allegations of death were alleged in the article.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MEDTRONIC; 9775 toledo way; irvine,ca
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9818120
• MDR Text Key: 189332893
• Report Number: 2029214-2020-00213
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/11/2020
• 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): Other