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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Stenosis (2263); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it was implanted in the patient.The device was not returned for analysis; therefore, the complaint of migration after deployment issue could not be confirmed, and the event cause could not be determined.It is possible that the reported mass effect of the partially thrombosed aneurysm induced parent vessel stenosis; this remodeling of the vessel caused the initial device to inadequately cover the aneurysm neck.Per our instructions for use (ifu): a thrombosed aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: ¿effect of antiplatelet therapy on thromboembolism after flow diversion with the pipeline embolization device¿ robert s.Heller, m.D., venkata dandamudi, m.D., michael lanfranchi, m.D., and adel m.Malek, m.D., ph.D.Medtronic received report that 23 patients with 26 intracranial aneurysms received a ped for treatment of their aneurysms.The mean age of 55.6 years (range 17¿77 years) and consisted of 5 men and 19 women.A single aneurysm required repeat treatment following the initial flow diverter embolization.Mass effect of the partially thrombosed aneurysm induced parent vessel stenosis; which remodel the vessel caused the initial flow diverter to inadequately cover the aneurysm neck, requiring deployment of a second device.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 6809869
• MDR Text Key: 83220620
• Report Number: 2029214-2017-00982
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• 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: 08/02/2017
• 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