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

Model Number PED-300-12

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 04/18/2017

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.The device was reported to have performed as intended; as there were no issue during the initial endovascular procedure.Intracranial hemorrhage is a known inherent risk of endovascular procedure and is documented in the device's instruction for use.The cause of the hemorrhage cannot be reliably determined; however, per the reported information, the most likely cause for the complaint is patient condition.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

Medtronic received report that approximately one month post embolization, the patient experienced a parenchymal hemorrhage.There we re no issues during the initial procedure.Aneurysm dimensions was reported to have 10 max diameter (mm), 4 neck diameter (mm).The landing zone (artery size) was 3 distal (mm) by 3 proximal (mm).

Manufacturer Narrative

Received the patient's current medical condition and the location of the hemorrhage.

Event Description

Medtronic received an update regarding the patient current medical condition: the patient was reported to be doing well and recovering nicely.The parenchymal hemorrhage was reported to have occurred distally to the treating location, but on the same side of the brain.

• Brand Name: PIPELINE FLEX
• 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: 6630166
• MDR Text Key: 77275057
• Report Number: 2029214-2017-00751
• 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
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2019
• Device Model Number: PED-300-12
• Device Catalogue Number: PED-300-12
• Device Lot Number: A328602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2016
• 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): Hospitalization