MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395); Activation Failure (3270)

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

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

Dodier, p., frischer, j.M., wang, w., auzinger, t., mallouhi, a., serles, w.,.Bavinzski, g.(2018).Immediate flow disruption as a prognostic factor after flow diverter treatment: long-term experience with the pipeline embolization device.World neurosurgery.Doi:10.1016/j.Wneu.2018.02.096 the pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices have not been returned; the reported events could not be confirmed.The causes of the event scould not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2018-00320 2029214-2018-00321 2029214-2018-00322 2029214-2018-00323.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of technical difficulties during pipeline placement.The purpose of this article was to report the long-term results after pipeline embolization device (ped) implantation.The authors retrospectively reviewed 40 patients with 59 aneurysms who underwent placement of 54 peds.The patients' mean age was 52.3 years; 34 of the patients were female.Balloon-dilatation of the ped was deemed necessary in 11 cases.The article states that balloon-dilatation was used during cases in which ped wall apposition was not achieved, in cases of tortuous internal carotid artery (ica) anatomy, or for suboptimal ped expansion.The article also states that the following deployment issues occurred: - immediate stent migration in two cases - delayed stent migration in one case - failed ped detachment in one case leading to abortion of the procedure.The patient did not experienced any neurological complication due to the aborted procedure.The article did not indicate that any patient adverse events occurred in association with these events.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7449970
• MDR Text Key: 106263221
• Report Number: 2029214-2018-00320
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• 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: 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