MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-77450-18

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Paralysis (1997)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient; therefore without return of the device, no definitive conclusions can be drawn regarding the clinical observation.The event occurred in the patient post procedure and its cause was unknown.Attempts were made to obtain additional information, however, no further information was provided.User context may have contributed to this event.Pipeline embolization device instruction for use provided this instruction, "after the entire ped is deployed, advance the micro catheter through the ped making sure not to dislodge the ped." same event as reported in mdr mfr: 2029214-2016-00243.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the first device placed foreshortened more than expected and a second device was placed to cover the aneurysm neck.The devices dislodged from the point of overlap and fell into the aneurysm.Patient was reported to be hemiplegic.No further information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha medtronic ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5596466
• MDR Text Key: 43271353
• Report Number: 2029214-2016-00242
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2017
• Device Model Number: FA-77450-18
• Device Lot Number: A020910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: 03/27/2016
• Supplement Dates FDA Received: 09/21/2017
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability