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

Catalog Number 1500275-33

Device Problems Failure to Advance (2524); Malposition of Device (2616); Difficult to Advance (2920)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous right coronary artery that is 80% stenosed.The vessel was prepared with orbital atherectomy and pre-dilatated with non-compliant 2.25mm and 2.5mm balloons.Buddy wire techinque was used with two non-abbott guide wires and a 2.75x33mm unspecified xience was attempted to be implanted at the distal portion of the lesion; however, was not able to advance all the way distally.The buddy wire was removed and the stent deployed from mid to proximal just after the first curve of the artery.Post dilatation was performed with a 3.0x12mm non-compliant balloon.A micro-catheter was used to deliver a 2.75x15mm xience sierra distally and post dilate with a non-compliant balloon.Finally, a 3.5x23mm xience sierra stent delivery system was attempted to be advanced; however, failed to cross due interaction with the 2.75x33mm xience stent that was previously implanted.Despite using the buddy wire, micro-catheter, further dilatation of the vessel, change of the sheath, the stent still failed to cross.Therefore, a non-abbott was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.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 not returned for analysis.The lot history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18998919
• MDR Text Key: 338879737
• Report Number: 2024168-2024-03871
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648218422
• UDI-Public: (01)08717648218422(17)260130(10)3021041
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500275-33
• Device Lot Number: 3021041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2023
• 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
• Treatment: 3.5X23MM XIENCE SIERRA