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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2017

Event Type  malfunction  

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 pipeline (ped) intraoperative deployment complications.The purpose of this article was to evaluate the risk of complications after flow diverter (fd) treatment vs.Fd + 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 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 deployment complications included accidental iatrogenic fd migration, intra-aneurysmal fd migration, distal fd misplacement, and simple deployment difficulties without relevant repercussion.The article states that deployment complications occurred in the following cases without specifying what type of deployment complication occurred.In case 9, the patient ((b)(6), male) underwent placement of a ped as well as two fds from another manufacturer in the treatment of a large, saccular intracavernous aneurysm (15mm).The patient experienced intraoperative fd deploy complication; the article does not specify which fd was involved.The patient's mrs was 0 post-operatively as well as one year post-operatively.In case 41, the patient ((b)(6), female) underwent placement of two peds in the treatment of a large, saccular supraclinoid aneurysm (18mm).The patient experienced intraoperative fd deploy complication.As of one year post-procedure, the patient's mrs was 0.

• 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: 7441617
• MDR Text Key: 105920342
• Report Number: 2029214-2018-00293
• 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?: 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: 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