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

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

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Based on the minimal information, the pipeline device performed as intended; as indicated by successful deployment of the device.No device issue was reported during the procedure.Hemorrhage (rupture of the aneurysm) is a known inherent risk of endovascular procedure and is documented in the pipeline instruction for use (ifu).Delayed aneurysm rupture after flow diversion occurs in approximately 1% of patients, and its mechanism may involve sudden hemodynamic changes in intra-aneurysmal flow pattern or aneurysm wall weakening due to inflammation and proteolytic enzymes within the developing red thrombus.The cause of the hemorrhage (aneurysm rupture) cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the complaint is patient condition.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 5 hours post the uneventful pipeline embolization procedure, the aneurysm ruptured.Post this even the patient was reported to have been doing well.The treating facility doesn¿t want to share details.

• 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: 7861181
• MDR Text Key: 119715909
• Report Number: 2029214-2018-00788
• 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
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/19/2018
• Initial Date FDA Received: 09/10/2018
• 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): Other