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

Model Number PED-400-14

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex remains implanted in the patient and will not be returned for evaluation.The reported event could not be confirmed and the event cause could not be determined from the reported information.

Event Description

Medtronic received report that a patient required retreatment after pipeline flex implantation.The patient underwent pipeline flex implantation to treat a saccular aneurysm in the right c6 internal carotid artery (ica).Aneurysm dome was 4.4mm and neck diameter was 3.4mm.Seven months post-procedure, it was discovered that the pipeline flex had migrated and foreshortened.There were no reports of patient injury as a result of the migration.One month later, the patient received an additional flow diversion device as a result of the migration.

Manufacturer Narrative

Additional information based on information obtained through follow up, the reported device foreshortening was related to the curve in the anatomy and balloon angioplasty procedure to improve wall apposition resulted in 3 mm neck coverage.Over the period of approximately six (6) months, there was straightening of the vessel curvature due to vessel remodeling resulting in the distal end of the device no longer covering the aneurysm neck.Based on our investigation this event is not related to a device failure, rather associated with patient anatomical location and physiological vessel remodeling.

Event Description

Medtronic received additional information: the pipeline flex had been deployed in a vessel curve.Balloon angioplasty was used for better wall apposition of the pipeline flex.Immediately post-procedure, the pipeline flex had 3mm of coverage distal to the aneurysm neck.The aneurysm landing zone artery diameter was 3.15mm distal and 4.15mm proximal.Seven months post-procedure, the patient underwent a follow up cerebral angiogram to assess the outcome of the pipeline flex implantation.It was reported that the distal end of the pipeline flex no longer covered the aneurysm neck.The angiogram showed that distal neck of the aneurysm was ¿only subtotally covered¿; the pipeline flex appeared to have had ¿interval minimal foreshortening¿.In addition, it was reported that ¿there is a tiny component of the distal device now partially projecting into the neck of the aneurysm.¿ the physician confirmed that the distal foreshortening of the device was related to the patient¿s anatomy and related to the vessel remodeling of the parent artery.There was no change to the aneurysm size.The patient was asymptomatic.Eight months after the initial pipeline flex implantation, an additional pipeline flex device was placed across the partially exposed neck of the aneurysm.The procedure resulted in flow stagnation within the aneurysm.

• 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 ; 9496801224
• MDR Report Key: 5511010
• MDR Text Key: 40691730
• Report Number: 2029214-2016-00153
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: PED-400-14
• Device Lot Number: A054755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Date Device Manufactured: 02/07/2015
• 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
• Patient Age: 00053 YR