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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during implantation.The event occurred in the patient post-procedure and its cause is not known.Tsai, y., <(>&<)> wong, h.(2016, june).Spontaneous migration of the pipeline embolization device: case report and review of the literature [abstract].Interventional neuroradiology, 22(1s), 21.Doi: 10.1177/1591019916648040.

Event Description

Medtronic received information from literature that a pipeline migrated after implantation.The patient underwent pipeline embolization device implantation and coil embolization of an unruptured, giant aneurysm in the distal internal carotid artery (ica).It was reported that at the three-month follow-up ct angiogram, distal migration of the pipeline was noted.The patient underwent placement of a second pipeline for coverage of the aneurysm.In the one-year follow-up angiogram, complete obliteration of the aneurysm was noted.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5897194
• MDR Text Key: 52795098
• Report Number: 2029214-2016-00745
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: 07/29/2016
• Supplement Dates FDA Received: 09/24/2017
• 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): Required Intervention
• Patient Age: 42 YR