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

Model Number PED-425-16

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for investigation as it was implanted in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.The event occurred in the patients post procedure and its cause was unknown.Additional information has been requested on this reported event, however, no response has been received.Should it become available a supplemental report will be submitted.¿ 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 post procedure embolization treatment with pipeline, the patient had small to medium level bleeding on the same day.The patient was recovered after one week later.The patient received this embolization treatment of an ic-piarachnoid, right, unruptured, fusiform, aneurysm with max diameter and neck width of 10.4 mm and 6.7 mm respectively one year ago.

Manufacturer Narrative

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

• 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 ; 9498373700
• MDR Report Key: 6540093
• MDR Text Key: 74281078
• Report Number: 2029214-2017-00617
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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: 04/16/2018
• Device Model Number: PED-425-16
• Device Lot Number: A091557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2015
• 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): Other
• Patient Age: 58 YR
• Patient Weight: 45