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

Model Number PED-350-16

Device Problem Material Separation (1562)

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

Event Date 05/19/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received report that the pushwire of a pipeline flex broke during procedure.At the end of the procedure and after successful implantation of the device, the physician tried to pull out the pushwire from the microcatheter; the distal part of the pushwire broke at the proximal site of the resheathing pad.The physician did not use force during this manipulation.Because the distal segment broke inside the microcatheter, the entire device was removed from the patient.No patient injury was reported as a result of this procedure.

Manufacturer Narrative

The device involved in this event has not been returned for evaluation.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).

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The pipeline pushwire and microcatheter were returned for evaluation without the pipeline as it was implanted in the patient.The pushwire was found outside the catheter.The pushwire appeared to be detached from the proximal wire weld.The distal hypotube was found to be stretched.The catheter appeared to be damaged at four different locations distally.An in-house mandrel was inserted through the catheter tip and hub and it got stuck at the damaged locations.The detached pushwire fragments were sent out for scanning electron microscope/energy dispersive using x-ray (analysis).The sem results showed a solder joint failure due to a tensile load that exceeded the strength of the solder joint.No other anomalies were observed.Based on the above findings and sem analysis, the customer's report was confirmed.It's likely a tensile overload that exceeded the strength of the solder joint.The pushwire and catheter were also damaged.However, the cause for damages could not be determined.All products are 100% inspected for damage and irregularities during manufacture.

• 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: 4882695
• MDR Text Key: 20779652
• Report Number: 2029214-2015-00695
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2018
• Device Model Number: PED-350-16
• Device Lot Number: A080406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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 Age: 49 YR
• Patient Weight: 49