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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient.Attempts to gather additional information have been made.However, our attempts have been unsuccessful.Based on the received information, there was no reasonably suggestion that a malfunction or quality deficiency of the pipeline device occurred during the treatment procedure.There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.However, the exact cause remains unknown.Neurological deterioration is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that post the uneventful pipeline embolization the patients (pre-medication for allergy) experienced stroke like symptoms and encephalopathy.A stroke series was run and did not indicate any sign of stroke and decadron cleared the symptoms completely.The patient received verapamil during surgery, however, the reason for this medication was not provided.

Manufacturer Narrative

Initial report with the treating facility information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that 24 hours post the uneventful pipeline embolization the patients (pre-medication for allergy of iodine (contrast)) experienced stroke like symptoms and encephalopathy.A stroke series was run and did not indicate any sign of stroke and decadron cleared the symptoms completely.The patient received verapamil during surgery to treat vasospasm (unknown what device caused this event).The patient was on dapt.

• 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: 7851343
• MDR Text Key: 119390586
• Report Number: 2029214-2018-00777
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• 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