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

Model Number PED-425-30

Device Problem Device Slipped (1584)

Patient Problem Fistula (1862)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The device will not be returned for analysis as it was implanted; therefore, the event cause could not be determined.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.

Event Description

Medtronic (covidien) received report that a pipeline flex dislodged after deployment.The patient was being treated for an unruptured, saccular aneurysm in the left petrous internal carotid artery (ica).The pipeline flex deployed well; no difficulties were noted.The physician attempted to balloon angioplasty the device to optimize wall apposition.During insertion of the balloon, the pipeline flex dislodged and the proximal end was in the aneurysm.Access to the device was lost.Several attempts to re-access using several microcatheters and wires were unsuccessful.During these attempts, a carotid cavernous fistula was formed within the aneurysm.Subsequently, the physician performed a vessel sacrifice of the left ica.There have been no updates on the patient's status.

Manufacturer Narrative

(b)(4).It was reported that the patient is doing well 3 weeks post procedure.

Event Description

Medtronic (covidien) received information that the patient is doing well 3 weeks post procedure.

• 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: 5031711
• MDR Text Key: 24112039
• Report Number: 2029214-2015-00917
• 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
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2018
• Device Model Number: PED-425-30
• Device Lot Number: A115412
• Other Device ID Number: 00836462015838180602A115412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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): Required Intervention; Disability
• Patient Age: 63 YR