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

Model Number 1804250-33

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Malposition of Device (2616); Deformation Due to Compressive Stress (2889)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.25x18mm xience skypoint delivery system (sds) referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a 90% stenosed lesion in the left anterior descending (lad) artery with mild calcification and mild tortuosity.A 2.75x18mm xience stent was implanted mid lad, followed by a 3.00x28mm xience stent implanted proximal mid lad and then a 3.00x12mm xience stent was deployed to overlap the 2 implanted stents.The 2.50x33mm xience skypoint stent delivery system (sds) was attempted to be advance to the target lesion; however the sds got stuck and could not advance or be removed from the implanted 3.00x28mm xience stent; therefore, the stent was deployed at the proximal/mid lad, which was not the intended location.Additionally, the sds catheter became kinked.After the stent was deployed, the sds was removed from the patient.At an unknown point during the procedure a 2.25x18mm xience skypoint sds was attempted to be advanced in the guide catheter, but the shaft broke while advancing through the guide catheter.The 2.25x18mm xience skypoint sds was simply removed from the patient, without issue.There was no adverse patient sequela and no clinically significant delay in the procedure.The procedure was completed with the implantation of 2 non-abbott stents.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 similar incidents from this lot.It was reported xience skypoint stent delivery system (sds) was stuck with the previously implanted stent while attempting to cross.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damage or dislodging the proximal stent.In this case, the instruction for use (ifu) deviation related to stenting out of order may have contributed to the reported difficulties.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously placed stent while crossing causing the reported failure to advance and difficulty to remove.The device was then deployed in the unintended location resulting in the reported malposition of the device and foreign body in patient.Handling and/or manipulation of the device during the reported difficulties likely caused the reported deformation due to compressive stress.The treatment appears to be related to operational circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 14964405
• MDR Text Key: 295595721
• Report Number: 2024168-2022-07419
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233111
• UDI-Public: 08717648233111
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: 10/27/2023
• Device Model Number: 1804250-33
• Device Catalogue Number: 1804250-33
• Device Lot Number: 1101341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: 2.75X18MM, 3.00X28MM, 3.00X12MM XIENCE STENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male