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

Model Number 1550350-15

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/20/2019

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 lesion in the right coronary artery (rca).A 3.5x15mm xience sierra stent delivery system (sds) was advanced; however, not deployed.The sds was removed from the patient and re-inserted over the wire.At this point, flaring was noted before the stent was inserted back into the patient anatomy.At some point during this process, a bend in the artery was noted and the undeployed stent dislodged and remained in the proximal rca.The patient was sent to another hospital for another cardiac catheter procedure.The stent was crushed in place with another stent and balloon.The patient is doing fine.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgment was confirmed.The reported material deformation could not be confirmed as the stent was not returned for analysis.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 identified no similar incidents from this lot.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) 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.Additionally, it should be noted that the ifu states: prior to using the xience sierra stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.In this case, it appears the instruction for use (ifu) deviation related to re-insertion and use after damage may have contributed to the reported event.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.The device was advanced and removed for an unknown reason.Damage (stent flaring) to the stent was noted prior to re-insertion; however, the device was re-inserted into the anatomy.It is likely the reported stent flare met resistance with the patient¿s anatomy as a bend in the artery was noted causing the reported stent dislodgement.It is likely the stent was damaged during the original advancement and/or removal of the device causing the reported stent flare.Additionally, the re-insertion of the device and the noted stent damage interacting with the patient¿s anatomy likely caused the reported stent dislodgement and subsequent treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9630016
• MDR Text Key: 176433140
• Report Number: 2024168-2020-00891
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: 09/29/2020
• Device Model Number: 1550350-15
• Device Catalogue Number: 1550350-15
• Device Lot Number: 9092341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 111