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

Model Number 1804225-12

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional xience skypoint device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that the first procedure was performed on (b)(6) 2023 to treat a lesion with four xience skypoint stent delivery systems (sds).A 2.5x23 mm and 2.25x12 mm xience skypoint stent were implanted in the mid left anterior descending coronary artery (mlad), one on the circumflex (cx), and the last one on the right coronary artery (rca).The patient was discharged on 1/06/23 with plavex.On the (b)(6) 2023 the patient experienced chest pain and was diagnosed with st elevated myocardial infarction (stemi).The lad was found to be under total thrombotic occlusion with in stent restenosis in the ostial,proximal, mid and distal lad with 100% stenosis.After pre dilating the lesion with a 3.25 non-compliant balloon (nc) to the proximal and distal stent in the mid lad and a 3.00mm non-compliant balloon (nc) in the distal lad.A 2.75x28 xience skypoint sds was implanted in mid lad, distal to the previously implanted stent.Reportedly, the stents were undersized to the vessel.No additional information was provided.

Event Description

Subsequent to the initially filed report, it was reported that it was the stents in the lad which were undersized [size chosen was small for the vessel].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.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect(s) of thrombosis, angina and myocardial infarction are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.Reportedly, the stents were undersized to the vessel.Subsequent to the initially filed report, it was reported that it was the stents in the lad which were undersized [size chosen was small for the vessel].It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: under-expansion of the stent may result in stent movement.Care must be taken to properly size the stent to ensure that the stent is in full contact with the arterial wall upon deflation of the balloon.All efforts should be made to ensure that the stent is not under-dilated.In this case, it cannot be determined if the instructions for use related to failure to follow steps/instructions caused and/or contributed to the reported patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code: 2588 removed.

• 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: 16765578
• MDR Text Key: 313541225
• Report Number: 2024168-2023-03980
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• 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: 05/26/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 2030141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male