MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EPIC¿ VASCULAR; STENT, ILIAC

Model Number H74939200081070

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05320.It was reported that tip detachment occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified left common iliac artery and the thrombosed previously placed wallstent in the external iliac artery (eia).The wallstent of eia and blood vessel were tortuous to an unbelievable extent.A non-bsc guide wire was advanced via right femoral approach but failed to cross.The device was then advanced via left femoral but it was still unable to cross.Subsequently, with the aid of a non-bsc sheath, the wire was advanced via left brachial but still failed.Approach was performed again via left femoral and the guide wire was able to cross.A 3mm-20mm sterling balloon catheter was advanced for pre-dilatation.Following plain old balloon angioplasty with a 6mm-60mm sterling balloon catheter, a 8x100x75 epic¿ vascular stent was placed.Upon removing the stent delivery system (sds) post-deployment, resistance was encountered.When the device was pulled, a snapping sound was heard.The sds was removed, however; it was noticed that the tip got detached and the detached fragment could not be found.The physician attempted to perform post-dilatation with a 6mm-60mm sterling balloon catheter but it failed to cross the sheath.The sheath was replaced with a 6fr-10cm non-bsc sheath, however; the balloon catheter still failed to cross.The procedure was completed and no further patient complications were reported.

Manufacturer Narrative

Describe event or problem, device evaluated by mfr., eval summary, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.The inner liner was detached and the tip was missing.The inner liner that was remaining showed kinks from the distal end of the markerband.The inner liner distal end damage looks like there may have been some tensile force applied due to the way the inner liner appears to be damaged and stretched.There may also have been interference with the introducer sheath that may have caused the separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The epic dfu states: use caution when withdrawing the stent delivery system and always manipulate under fluoroscopy.If unusual resistance is felt, re-advance and rotate the delivery system to center the delivery system within the vessel, then carefully attempt repeat withdrawal.(b)(4).

Event Description

It was further reported that there was no attempt to remove the detached fragment as the tip could not be found and the patient's status post procedure was stable.

• Brand Name: EPIC¿ VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7548569
• MDR Text Key: 109372367
• Report Number: 2134265-2018-04560
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805571
• UDI-Public: 08714729805571
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: 04/09/2022
• Device Model Number: H74939200081070
• Device Catalogue Number: 39200-08107
• Device Lot Number: 0020510511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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
• Treatment: GUIDEWIRE: TREASURE ASTATO TREASURE FLOPPY; INTRODUCER SHEATH:DESTINATION 6FR×2 SHEATHLESS PV
• Patient Outcome(s): Other