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

Model Number PED-400-30

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

Patient Problems Occlusion (1984); Foreign Body In Patient (2687)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex device will not be returned for evaluation as it was implanted in the patient.The device was not returned, therefore the reported event could not be confirmed and an event cause could not be determined from the reported information.Mdrs related to this event: 2029214-2016-00816, 2029214-2016-00817.

Event Description

Medtronic received report that a pipeline flex did not open during a procedure.The patient was undergoing treatment for an unruptured, fusiform aneurysm in the left cavernous internal carotid artery (ica).The vessel was moderately tortuous.The aneurysm max.Diameter was 25mm and neck diameter was 7mm.Landing zone artery size was 3.8mm distal and 4.1mm proximal.The devices were prepared as indicated in the ifu.It was reported that during attempt of a pipeline flex, the device was deployed across the aneurysm neck.The physician felt that the device could be more open in the middle section; a j-wire was used to "bump" against the pipeline.While doing this, the proximal end of the pipeline "flew up" and landed in the aneurysm; the distal section of the pipeline remained in the cavernous ica.The physician lost wire access to the pipeline.The physician attempted several retrieval devices, without success.The procedure was ended.The next day, the physician performed a balloon occlusion test and decided to implant a microvascular plug for a vessel sacrifice.There were no reports of patient symptoms.

Manufacturer Narrative

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

• 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: 5957579
• MDR Text Key: 54991830
• Report Number: 2029214-2016-00817
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

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
• Device Expiration Date: 05/13/2018
• Device Model Number: PED-400-30
• Device Lot Number: A106519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; 11/14/2016
• Supplement Dates FDA Received: 11/14/2016; 09/25/2017
• Date Device Manufactured: 05/14/2015
• 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: 55 YR