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

Catalog Number 1500400-18

Device Problems Break (1069); Difficult to Remove (1528); Difficult or Delayed Activation (2577)

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

Event Date 11/17/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with moderate calcification and moderate tortuosity.The 4.0x18mm xience sierra stent delivery system (sds) was noted to have a fracture between the metal and plastic casing [shaft] during the procedure but remained intact and resulted in the inability to deploy contrast to the balloon.The stent was partially deployed but balloon remained stuck to the internal structure of the stent.The balloon and sds were removed, however, the stent needed to be further expanded with the use of multiple balloons.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device 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 other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported shaft break; however, reported difficult stent activation, difficult to remove and subsequent treatment appear to be related to the operational context of the procedure.In this case, it is possible that inadvertent mishandling and/or manipulation of the stent delivery system during the procedure may have contributed to the reported shaft break; however, this cannot be confirmed.Additionally, it was reported that the shaft break resulted in the inability to deploy contrast to the balloon, resulting in the reported difficult stent activation.The difficult stent activation likely contributed to an interaction between the balloon and deployed stent, resulting in the reported difficult to remove.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: 15988244
• MDR Text Key: 305529705
• Report Number: 2024168-2022-12680
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500400-18
• Device Lot Number: 2041441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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 Outcome(s): Required Intervention