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

Model Number PED-400-16

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. The report of migration after deployment event could not be confirmed, and the event cause could not be determined. It is possible that braid sizing may have contributed to the reported issue. Per our instructions for use (ifu): do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter. Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel. An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration. No lot history record review is required as there is no allegation or evidence of potential or confirmed manufacturing issues. All products are 100% inspected for damages and irregularities during manufacture.

Event Description

Medtronic received report that the flow diverter was alleged to have ¿shrunk¿. This event was reported to have required intervention. The patient was initial treated on (b)(6) 2016, as (b)(6) 2016, the patient was reported to have recover. Aneurysm was in the right internal carotid cavernous, unruptured, saccular, with max diameter 11. 3 mm, neck width 5. 4 mm. The aneurysm was found by mri taken due to dizziness.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6587475
• MDR Text Key: 106866929
• Report Number: 2029214-2017-00698
• 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: foreign,health professional,s

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/02/2018
• Device Model Number: PED-400-16
• Device Lot Number: A083990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/24/2017 Patient Sequence Number: 1