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

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467)

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Occlusion (1984); Paresis (1998)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Peschillo, s., caporlingua, a., resta, m.C., peluso, j.P., burdi, n., sourour, n.,.Resta, m.(2017).Endovascular treatment of large and giant carotid aneurysms with flow-diverter stents alone or in combination with coils: a multicenter experience and long-term follow-up.Operative neurosurgery, 13(4), 492-502.Doi:10.1093/ons/opx032 the pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices were not returned; the reported events could not be confirmed.The cause of the events could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2018-00292 2029214-2018-00293.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of intraoperative or post-operative pipeline (ped) complications.The purpose of this article was to evaluate the risk of complications after flow diverter treatment vs.Flow diverter + coil treatment of large/giant internal carotid artery (ica) aneurysms.The authors reviewed 44 patients with large or giant ica aneurysms: 26 patients underwent treatment using flow diverters (fd) alone and 18 patients underwent treatment using fd + coils.Of the 44 patients, 12 were male and 32 were female; mean age was 58.3 years.The article states that the following intraoperative or post-operative complications occurred: in case 3, the patient ((b)(6) male) underwent placement of a ped and another manufacturer's fd in the treatment of a large, saccular supraclinoid aneurysm (16mm).The article states that intraoperative complications included aneurysmal rupture and fd deploy complication (the article does not specify which fd was involved).The patient's post-operative mrs was 4; one-year follow-up mrs was 3.In case 4, the patient ((b)(6) female) underwent placement of a ped in the treatment of a large, fusiform intracavernous aneurysm (20mm).The patient experienced post-operative hemiparesis.The patient's mrs was 5 post-operatively and was 1 one-year post-procedure.In case 39, the patient ((b)(6) female) underwent placement of two peds in the treatment of a giant, saccular intracavernous aneurysm (27mm).The article indicates that the patient experienced intraoprative fd deploy complication as well as parent artery stenoocclusion.Post-operatively, the patient experienced transient hemiparesis.The patient's mrs was 1 post-operatively and was 0 one year later.In case 42, the patient ((b)(6) female) underwent placement of a ped in the treatment of a large, saccular intracavernous aneurysm (22mm).The patient experienced intraoperative thromboembolism.In addition, the patient experienced post-operative transient hemiparesis.The patient's mrs was 2 post-operatively and was 0 one year later.In case 43, the patient ((b)(6) female) underwent placement of two peds in the treatment of a large, saccular intracavernous aneurysm (22mm).The patient experienced intraoperative fd deploy complication as well as thromboembolism.The patient's post-operative and one-year follow-up mrs were both 0.In case 44, the patient ((b)(6) female) underwent placement of a ped in the treatment of a large, saccular supraclinoid aneurysm (18mm).The patient experienced intraoperative thromboembolism as well as post-operative slight motor aphasia.The article states that the aphasia was likely due to fd-mediated occlusion of lenticulostriate artery/arteries.The patient's mrs post-operatively and one year later were both 2.The article states that deployment complications included accidental iatrogenic fd migration, intraaneurysmal fd migration, distal fd misplacement, and simple deployment difficulties without relevant repercussion.The article does not specify what type of deployment complication each patient experienced.

• 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: 7441612
• MDR Text Key: 105874832
• Report Number: 2029214-2018-00292
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• 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: 03/26/2018
• 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
• Patient Outcome(s): Other