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

Model Number 1804350-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiac Arrest (1762); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 03/10/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a procedure was performed to treat lesions in the proximal and mid left anterior descending (lad) vessels.Two non-abbott stents were implanted in the first marginal and proximal to mid lad lesions.On (b)(6) 2023, restenosis was noted in the first marginal which was treated with a drug coated balloon.On (b)(6) 2023, restenosis was observed in the proximal to mid lad.The 3.5x28mm xience skypoint stent was implanted in the proximal to mid lad, overlapping the previously implanted stent for treatment.No abnormity was noted with the xience stent or flow after stent implantation.On (b)(6) 2023, the patient returned to the hospital.The patient was experiencing chest pain and was in a state of cardiopulmonary arrest (cpa).Imaging confirmed total occlusion from distal of the implanted xience stent.Thrombus aspiration was performed; however, did not aspirate much thrombus.Reperfusion was performed with balloon dilatation, but the patient did not recover.The following day the patient expired.No additional information was provided.

Event Description

Subsequent to the previously filed report, the following correction was made: prior to the restenosis noted on (b)(6) 2023, the order of events were as follows on (b)(6) 2022, a non-abbott stent was implanted in the stenosed lesion of the first marginal coronary artery.On (b)(6) 2022, a non-abbott stent was implanted in the proximal to mid left anterior descending (lad) coronary artery.

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.The reported patient effect(s) of thrombosis, angina and death are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.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.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.B5: describe event or problem.

• 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: 16685652
• MDR Text Key: 312734063
• Report Number: 2024168-2023-03542
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: 08717648233425
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 107194A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG