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

Catalog Number 1500275-23

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Medical device problem code 2017: re-insertion.

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous circumflex artery.The 2.75x23mm xience sierra stent delivery system met resistance during advancement with anatomy and was removed.Therefore, balloon dilatation was performed and again the sds was attempted to advance; however, it was noted the stent began to lift and the stent began to release [dislodge].There was difficulty felt with anatomy during removal of the device.Another abbott stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance and difficult to remove could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It was reported that the xience sierra failed to advance in the lesion and was removed, then the same device was reinserted.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) specifies: 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 dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely the device interacted with the heavily calcified, heavily tortuous lesion during advancement, contributing to the reported failure to advance and material deformation (stent damage).Further interaction with the challenging anatomy and damaged stent likely contributed to the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.C8, #1: event abated after use stopped? updated.H6: medical device problem code 2923 was removed, replaced with 2976.

Event Description

Subsequently, after the initial was filed it was noted by the stent began to release it was meant that the stent struts were flared.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18636074
• MDR Text Key: 334541449
• Report Number: 2024168-2024-01369
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500275-23
• Device Lot Number: 2033041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Patient Sex: Male