MAUDE Adverse Event Report: COVIDIEN (IRVINE) PED-250-18; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-250-18

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Occlusion (1984); No Code Available (3191)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned as it was implanted in the patient.Attempts have been made to obtain additional information.However, our attempts have been unsuccessful.Thrombus formation and dissections/ injuries are known inherent risk of the endovascular procedures and is documented in our devices¿ instructions for use (ifu).Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the devices occurred during the treatment procedure.There is no evidence suggesting that the devices were defective, but rather a procedure and patient condition related event and the exact cause is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through a health care professional conference.One case that was presented stated that 18 months after the uneventful the pipeline embolization procedure, the pipeline was alleged to have been occluded.This event was treated with 9f cello and 3 max (aspiration only).A dissection was alleged to have occurred because of the cello being in the carotid, wh ich was subsequently stented.The aneurysm was in the left pcom, which recurred after 6 months post initial coil treatment.Prior to the procedure, the patient was on asa only for 10 days with no issues.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: PED-250-18
• 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: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7720544
• MDR Text Key: 115060570
• Report Number: 2029214-2018-00657
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-250-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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