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

Model Number PED-350-18

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Occlusion (1984); Therapeutic Response, Decreased (2271)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

The pipeline flex with shield device will not be returned for evaluation as it was implanted in the patient.Based on the provided photos, the report of migration after deployment was confirmed.The device was not returned for analysis, therefore the event cause could not be conclusively determined.All products are 100% inspected for damages and irregularities during manufacture.It is possible that braid sizing and the patient¿s severely tortuous vessel anatomy may have contributed to the reported issue.The pipeline flex with shield instructions for use (ifu) provides the following guidance: ¿choose an appropriately sized pipeline flex embolization device with shield technology such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device with shield technology may result in inadequate device placement, incomplete opening, or migration.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ concomitant medical product: pipeline flex with shield technology model number: ped2-350-18.Mdrs related to this event: 2029214-2017-00626 2029214-2017-00627 2029214-2017-00628.

Event Description

Medtronic received report that three pipeline flex with shield devices migrated after placement.The patient was undergoing treatment for an unruptured, saccular aneurysm in the ophthalmic internal carotid artery (ica).The aneurysm measured 20mm x 18mm.The landing zone artery size was 3mm distal and 3.9mm proximal.The vessel was severely tortuous.The devices were prepared as indicated in the ifu.It was reported that a pipeline flex with shield (ped2-375-20, lot a356814) was deployed without issue.After detaching the device, the braid migrated proximally leaving the aneurysm neck uncovered.A second pipeline flex with shield (ped2-375-18, lot a358492) was placed and the same issue occurred ¿ the braid migrated proximally.A third pipeline flex with shield (ped2-350-18, lot a349240) was placed without any issue.Afterward, the physician began coiling the aneurysm using the jailed microcatheter technique.At that time, the third pipeline flex migrated within the first two pipeline devices.The physician completed embolization by placing 28 coils, then embolized the artery.The patient¿s flow is reportedly compensated through the other side.

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: 6553261
• MDR Text Key: 74698235
• Report Number: 2029214-2017-00628
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2019
• Device Model Number: PED-350-18
• Device Lot Number: A349240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Date Device Manufactured: 09/23/2016
• 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: 70 YR
• Patient Weight: 70