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

Model Number FA-77475-16

Device Problems Break (1069); Difficult or Delayed Positioning (1157)

Patient Problem Infarction, Cerebral (1771)

Event Date 05/13/2015

Event Type  Injury  

Event Description

Medtronic (covidien) received information that during flow diversion treatment of an unruptured saccular right ophthalmic carotid aneurysm, the physician could not get the pipeline to come out of the capture coil.The anatomy was moderately tortuous.The physician did all of the necessary things to detach from the capture coil, but the pipeline would not open distally.He did seven clockwise rotations total.The distal wire broke and the pipeline was deployed.The distal wire was still attached to the pipeline distally.The physician was going to snare the pipeline, but was afraid the distal wire would migrate and would not be able to be retrieved.Instead, the physician did a vessel sacrifice with forty coils.Patient had a slight stroke.The pushwire was discarded and will not be returned.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The pipeline will not be returned for analysis as it was implanted and the pushwire was discarded; therefore, the event cause could not be determined.

• Brand Name: PIPELINE 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: 4821833
• MDR Text Key: 5897284
• Report Number: 2029214-2015-00632
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2018
• Device Model Number: FA-77475-16
• Device Lot Number: A049947
• Other Device ID Number: 00836462014657180127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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: 69 YR