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

Catalog Number 1508350-33

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

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

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was reported that during preparation of the 3.5x33mm xience pros stent delivery system (sds) it was not possible to remove the yellow cover from the device.Extra force was used; however, was unsuccessful.The stent became damaged and dislodged in the yellow cover.There was no patient involvement and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement was confirmed.The reported difficulty to remove the sheath could not be confirmed due to the condition the device was 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 other incidents from this lot.It was reported that during preparation of the 3.5x33mm xience pros stent delivery system (sds) it was not possible to remove the yellow cover from the device.Extra force was used; however, was unsuccessful.It should be noted that the xience sierra (pro s) everolimus eluting coronary stent system instruction for use states: remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent, and with the other hand, grasp the stent protector and gently remove distally.If unusual resistance is felt during product mandrel and stent sheath removal, do not use this product and replace with another.In this case, it does not appear that the instruction for use (ifu) deviation related to excessive force during sheath removal caused the reported event.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the sheath.The reported stent dislodgment appears to be related to operational context of the procedure as it is likely handling and/or the excessive force used during the difficult removal of the sheath caused the reported stent dislodgment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PROS 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: 17087170
• MDR Text Key: 316846474
• Report Number: 2024168-2023-06034
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1508350-33
• Device Lot Number: 3022241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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