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

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Almandoz, j.E., kayan, y., tenreiro, a., wallace, a.N., scholz, j.M., fease, j.L.,.Tenreiro-picón, o.(2017).Clinical and angiographic outcomes in patients with intracranial aneurysms treated with the pipeline embolization device: intra-procedural technical difficulties, major morbidity, and neurological mortality decrease significantly with increased operator experience in device deployment and patient management.Neuroradiology, 59(12), 1291-1299.Doi.Org/10.1007/s00234-017-1930-z the pipeline device will not be returned for evaluation as they were implanted in the patients.The devices was not returned; the events described in this article could not be confirmed.The cause of the events could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2018-00220 2029214-2018-00221 2029214-2018-00222 2029214-2018-00223 2029214-2018-00224.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of technical difficulty during pipeline procedures.The purpose of this article was to determine whether outcomes after pipeline (ped) treatment improve with operator experience.The authors retrospectively reviewed 140 patients who underwent 150 ped procedures to treat 167 intracranial aneurysms.Of the patients, 109 were women and 31 were men; the mean age was 55.4 years.The article states that intraprocedural difficulties included four successfully bridged intra-aneurysmal ped herniations and four ped stenoses requiring balloon angioplasty.

• 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: 7366023
• MDR Text Key: 103528982
• Report Number: 2029214-2018-00220
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• 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