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

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the article photos, the reported event was confirmed.However, the device was not returned for analysis, therefore the event cause could not be conclusively determined.Park, m.S.(2016).Re-treatment rates after treatment with the pipeline embolization device alone versus pipeline and coil embolization of cerebral aneurysms: a single-center experience.Journal of neurosurgery, 125(1), 137-144.Doi:10.3171/2015.7.Jns15582 mdrs related to this article: 2029214-2016-00682, 2029214-2016-00683, 2029214-2016-00684, 2029214-2016-00685, 2029214-2016-00686, 2029214-2016-00687, 2029214-2016-00688, 2029214-2016-00689, 2029214-2016-00690, 2029214-2016-00691, 2029214-2016-00692, 2029214-2016-00693, 2029214-2016-00694, 2029214-2016-00695, 2029214-2016-00696, 2029214-2016-00697, 2029214-2016-00698, 2029214-2016-00699, 2029214-2016-00700, 2029214-2016-00701, 2029214-2016-00702 2029214-2016-00703, 2029214-2016-00704, 2029214-2016-00705, 2029214-2016-00706, 2029214-2016-00707 2029214-2016-00708, 2029214-2016-00709, 2029214-2016-00710 2029214-2016-00711, 2029214-2016-00712 2029214-2016-00713, 2029214-2016-00714.

Event Description

Medtronic received information from literature that a patient underwent retreatment after pipeline implantation.The patient had an aneurysm in the right, posterior communicating (pcom) artery.The aneurysm size was 8.5mm.The aneurysm had recurred after clipping.One pipeline device was implanted.The six-month follow-up angiogram demonstrated continued filling of the aneurysm.Imaging also showed contraction of the distal section of the pipeline exposing the aneurysm neck.A second pipeline was implanted telescoping the first.Nine-month follow-up showed complete occlusion of the aneurysm.

Manufacturer Narrative

Correction to related mdrs: 2029214-2016-00683, 2029214-2016-00684, 2029214-2016-00685, 2029214-2016-00686, 2029214-2016-00687, 2029214-2016-00688, 2029214-2016-00689, 2029214-2016-00690, 2029214-2016-00691, 2029214-2016-00692, 2029214-2016-00693, 2029214-2016-00694, 2029214-2016-00695, 2029214-2016-00696, 2029214-2016-00697, 2029214-2016-00698, 2029214-2016-00699, 2029214-2016-00700, 2029214-2016-00701, 2029214-2016-00702, 2029214-2016-00703, 2029214-2016-00704, 2029214-2016-00705, 2029214-2016-00706, 2029214-2016-00707, 2029214-2016-00708, 2029214-2016-00709, 2029214-2016-00710, 2029214-2016-00711, 2029214-2016-00712, 2029214-2016-00713, 2029214-2016-00714, 2029214-2016-00715.

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: 5855611
• MDR Text Key: 51443658
• Report Number: 2029214-2016-00683
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 08/08/2016
• 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: 61 YR