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

Model Number FA-77400-20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline flex push wire has not been returned for evaluation; the remainder of the device was implanted in the patient.The lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.The event cause could not be determined.(b)(4).

Event Description

Medtronic (covidien) received a report that a pipeline was stuck in the capture coil and the push wire broke.The basilar artery was accessed and the pipeline was advanced.At deployment, the capture coil would not release the pipeline, so the physician decided to remove the device by corking (trapping the pipeline braid between the capture coil and the catheter.) when attempting to cork the pipeline, the physician was able to move the pipeline from the basilar artery into the right vertebral artery, but the proximal end of the pipeline deployed.It was apparent that the.008 wire broke.The pipeline was in the vessel and the distal end was still constrained by the capture coil with the distal wire attached.The vessel was sacrificed by implanting five coils and nbca glue.

Manufacturer Narrative

The pipeline pushwire was returned for evaluation without the pipeline or the microcatheter.It was confirmed that the pushwire was separated into two segments (distal and proximal).Only the proximal segment of the pushwire was returned for investigation.Per the initial report, the distal segment remains inside the patient.The pushwire was found to be broken 5.5cm from the proximal bumper and appeared to be bent 64cm to 111.5cm from the proximal end.The coating was found intact except 17cm to 30cm from the proximal end.The broken end was sent out for sem analysis.Based on evaluation and sem analysis of the pushwire, the complaint of pushwire separation was confirmed.The push wire appeared be separated due to torsional overload.The complaint of pipeline stuck in capture coil could not be confirmed since the distal section of the push wire was not returned; the cause could not be determined.The lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.(b)(4).

• 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: 5094986
• MDR Text Key: 26465793
• Report Number: 2029214-2015-00996
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/26/2015

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: 08/21/2016
• Device Model Number: FA-77400-20
• Device Lot Number: 9792447
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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: 51 YR