MAUDE Adverse Event Report: COVIDIEN (IRVINE) APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number 105-5096-000

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Medtronic received information that during the procedure, the physician navigated the apollo catheter via a mirage wire to the posterior fossa with no friction.As the physician was positioning the apollo catheter; the tip detached at the detachment zone within the vessel.The physician attempted to remove the tip with a 3 mm alligator however the alligator was unable to grasp the tip successfully.The physician then used a 4 mm gooseneck snare to capture and remove the 3 cm tip successfully.The case was successfully completed by using onyx 18 and a different apollo 1.5 cm.The patient was reported to be well at the end of the procedure.No other complications were reported.

Manufacturer Narrative

The apollo catheter and the detachable tip were returned for investigation.It was confirmed that the tip was detached from the catheter.No other defects were noted on the catheter body.Based on the above findings, the customer's report was confirmed.However, the cause for the experience reported could not be determined.All products are 100% inspected for damage and irregularities during manufacturing.The lot history record of the reported lot number has been reviewed and no quality issues were noted.(b)(4).

• Brand Name: APOLLO
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4795846
• MDR Text Key: 5818724
• Report Number: 2029214-2015-00593
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004/S006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2018
• Device Model Number: 105-5096-000
• Device Lot Number: A048385
• Other Device ID Number: 00836462002487180108A048385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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: 46 YR