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

Model Number PED-450-20

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Visual Impairment (2138)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Srinivasan, v.M.Et al.(2017).Prolapse of the pipeline embolization device in aneurysms: incidence, management, and outcomes.Neurosurgical focus, 42(6).Doi:10.3171/2017.3.Focus1738 the pipeline flex device remains implanted in the patient; product analysis cannot be performed.The reported event could not be confirmed; an event cause could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2017-00862, 2029214-2017-00863, 2029214-2017-00864.

Event Description

Medtronic literature review found reports of pipeline flex migration after implantation.The purpose of this article was to determine the incidence of pipeline (ped) foreshortening or migration leading to prolapse as well as to review rescue strategies and outcomes.The authors identified three cases of ped foreshortening leading to prolapse.The article states that in case 1, the patient underwent ped implantation in the treatment of a large, right cavernous ica aneurysm, measuring 20x14 mm with a 13-mm neck.There was significant proximal vessel tortuosity.During the procedure, the 4.5x20mm pipeline flex was deployed across the aneurysm neck in the cavernous ica, with more attention given to having sufficient distal coverage, leaving a shorter proximal segment.The article states that deployment of a second ped was considered, but there was concern of pushing the proximal end of the ped into the aneurysm while attempting to reaccess the device.Early stasis was observed, and the procedure was considered successful.After initial improvement of pre-existing lateral rectus palsy, the patient developed acute worsening of diplopia at 4 months.Angiographic follow-up at 6 months showed that the proximal end of the ped had migrated into the dome of the aneurysm.The patient declined further intervention as symptoms were tolerable.The patient was maintained on dual antiplatelet therapy thereafter, with no change in the aneurysm on follow-up ct angiography (cta) at 12 months.

• Brand Name: PIPELINE FLEX 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: 6696950
• MDR Text Key: 79511825
• Report Number: 2029214-2017-00862
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• 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
• Patient Age: 84 YR