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

Model Number PED-500-35

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Per the device¿s instructions for use (ifu) ¿caution: the presence of other indwelling endovascular stents may interfere with proper deployment and function of the ped.¿ ¿use fluoroscopy to carefully monitor the tip of the core wire during ped deployment.¿ ¿ped fo reshortens substantially (50-60%) during deployment.Take device foreshortening into account when deploying ped.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the pipeline embolization procedure, there was a gap between the pipeline construction between the first and the second.At the time of deployment, pushing with the catheter was insufficient, the second pipeline did not deploy to 5 mm in diameter.While trying to use a competitor balloon to better achieve full wall apposition, the balloon allegedly did not pass through the second ped's bending section and pushed the pipeline which prevented the proximal part of the pipeline from being delivered.The proximal part of the ped which stuck in the proximal vessel of the aneurysm was pushed by the balloon and advanced into the aneurysm sac.The proximal part of the second pipeline did not move in the distal direction.The balloon was in the deployed pipeline which was bent in the aneurysm, the tip of the balloon got stuck at the net of the pipeline and did not advance.During this maneuver, the pipeline was alleged to have injured the internal carotid and a hemorrhage occurred.Per the procedure imaging, the bleeding was not inside of the aneurysm and within the proximal blood vessel or epidural, therefore another pipeline was implanted, the procedure ended.The patient was reported to be under observation for carotid-cavernous fistula (ccf).The surgical time was extended by more than 30 min.Vessel diameter was slightly large and was not tortuous.The devices were are prepared and used per the instructions for use.No images are available.

Event Description

Additional information received noted that inside the first pipeline at the proximal part, the second pipeline was overlapped and deployed.For the position of the second pipeline the distal part was in the first pipeline and overlapped, the central part was in the aneurysm, and the proximal part was in the proximal vessel of the aneurysm.The proximal part which stuck in the proximal vessel of the aneurysm was pushed by the scepter and advanced into the aneurysm.The scepter was in the deployed pipeline which was bent in the aneurysm, the tip of the scepter got stuck at the net of the pipeline and did not advance.At the time of deployment the pushing with the catheter was insufficient and the pipeline did not deploy to 5mm in diameter, with the diameter of the second pipeline smaller than that of the first and a gap of about 1mm between the first and second.Therefore, a balloon was used to expand the second pipeline from the inside.For the movement of the balloon it was noted that it advanced from the proximal vessel into the aneurysm.It was confirmed that the pipeline opened normally.The device were prepared as indicated per the ifu.It is unknown if a continuous flush was used.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8170122
• MDR Text Key: 130529290
• Report Number: 2029214-2018-01077
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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: 05/08/2021
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: A642752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention