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

Model Number PED-475-20

Device Problem Migration (4003)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Device migration is a known inherent risk of endovascular procedure and is documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.The event could not be confirmed, as cause of the event could not be definitively determined.Per the instructions for use (ifu): select an appropriately sized ped such that it is fully expanded diameter is equivalent to that of the largest target vessel diameter.An incorrectly sized ped may result in inadequate device placement, incomplete opening, or distal migration.Anchor ped at least 2-3 mm into the proximal and distal segments of the parent artery, preferably in a straight portion of the parent artery.Use fluoroscopy to carefully monitor the tip of the core wire during ped deployment.Ped foreshortens substantially 50-60%) during deployment.Take device foreshortening into account when deploying ped.Linked with mdrs: 2029214-2019-00195, 2029214-2019-00196.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: ¿endovascular management of spontaneous delayed migration of the flow-diverter stent.¿ yuan-hsiung tsai, ho-fai wong, shih-wei hsu, da et.Al.Patient 2: (b)(6) female: the aneurysm measured 1.9 × 1.1 cm, without a significant neck.The diameter of the inflow vessel was 4.6 mm, and the diameter of the outflow vessel was 3.6 mm.Due to the location, size and wide neck of the aneurysm, the decision was made to treat the aneurysm with an fd.The patient received a dual anti-platelet regimen for 5 days prior to treatment.With the use of a tri-axial system, a 4.75 × 20 mm ped (ped-475-20) was deployed across the aneurysm.Cone-beam ct showed adequate stent apposition to the vessel wall with covering of the neck, and the control angiogram demonstrated adequate ped placement with contrast stasis in the aneurysm sac and a typical ¿eclipse sign¿.The procedure was uneventful, and the patient was dismissed without neurological deficits.The ocular symptoms were improved.However, the patient suffered from sudden-onset recur-rent ptosis at 3 months after fd placement.Dsa and cone-beam ct showed distal migration and shortening of the ped, causing the neck of the aneurysm to no longer be covered by the device.A significant mismatch in the diameters of the proximal and distal landing zones might have been the reason for the migration.Due to economic considerations and the family¿s questioning of the treatment effect of a 2nd fd, the decision was made to treat the aneurysm with the traditional stent-assisted coiling technique.A closed-cell stent (enterprise, johnson & johnson, new brunswick, nj, usa) was deployed to cover the whole ped to pre-vent further migration and to cover the neck of the aneurysm for stent-assisted coiling with the jail technique.Dsa 6 months after stent-assisted coiling showed partial obliteration of the aneurysm with minimal filling of contrast in the aneurysmal sac.

• Brand Name: PIPELINE FLEX
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8420176
• MDR Text Key: 138777070
• Report Number: 2029214-2019-00197
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P100018.S011
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: No
• 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