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

Model Number PED-450-16

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure event.The event occurred in the patient post-procedure and an event cause could not be conclusively determined from the reported information.Intracerebral bleeding and hemorrhage are known inherent risks of the flow diversion procedure and is documented in the pipeline flex instruction for use.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 information that approximately 7 days post procedure the patient experienced an intraparenchymal hemorrhage on the contralateral side to the pipeline implant.The patient was admitted to the hospital (b)(6) 2016.The pipeline device was implanted to treat an unruptured, saccular, peri-opthalmic aneurysm.The vessel tortuosity was normal.Dual anti-platelet therapy (dapt) was administered and pru was 205 upon readmission.Angiographic result was good post procedure, however 7 days post procedure the patient experienced an intraparenchymal hemorrhage.As of (b)(6)2016 the patient is doing well with no further progression of symptoms.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 9498373700
• MDR Report Key: 6234050
• MDR Text Key: 64206437
• Report Number: 2029214-2017-00027
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

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
• Device Expiration Date: 10/20/2017
• Device Model Number: PED-450-16
• Device Lot Number: A048450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: 12/23/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2014
• 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