MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1500250-18

Device Problems Entrapment of Device (1212); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, heavily tortuous.95% stenosed left anterior descending coronary artery.An unspecified balance middleweight guide wire and unspecified 2x8 balloon were advanced for pre-dilatation.A 3x18mm xience sierra stent delivery system (sds) was advanced, and the stent was implanted successfully.Then, a 2.5x18mm xience sierra sds failed to cross.Unspecified dilatation was performed, but the sds failed to cross for a second time.However, this sds became stuck in the previously implanted stent, and this sds' stent struts became bent.A snare was used to retrieve the second sds, and the first stent was confirmed to be fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial report, the following information was received: after the 3x18mm xience sierra stent was implanted successfully in the proximal left anterior descending coronary artery, a 2.5x18mm xience sierra stent delivery system was attempted to be advanced to the side branch but failed to cross the lesion.On attempting to remove the delivery system, resistance with the previously deployed stent was met.The delivery system was removed to the left main with stent deformation and elongation, and the stent dislodged.A snare was used to remove the dislodged stent.Further balloon dilatation was performed to the deployed stent in the lad and the ultimate result was acceptable.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned stent.The reported device damage, stent dislodgement, stretched stent, material deformation and entrapment of the device were confirmed.The reported failure to advance and device damaged/caused damage could not be tested as they were based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.The investigation determined the reported difficulties and subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11095916
• MDR Text Key: 224394835
• Report Number: 2024168-2020-11010
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Catalogue Number: 1500250-18
• Device Lot Number: 9010741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3X18 XIENCE SIERRA STENT; BALANCE MIDDLEWEIGHT GUIDE WIRE; 3X18 XIENCE SIERRA STENT
• Patient Outcome(s): Required Intervention