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

Model Number 1125300-38

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/01/2021

Event Type  Injury  

Event Description

It was reported through a research article that a non-abbott stent was implanted in the left circumflex artery, but protruded into the left main artery.One month later, during implantation of a 3.0x38mm xience alpine stent in the left main artery to the anterior descending coronary artery, it was noted that the wall apposition was poor around the area of the previously implanted non-abbott stent.At the area of malapposition, thrombus was noted.Treatment is unknown.For complete reported information, please see the attached article, titled ¿napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation.".

Manufacturer Narrative

Date of event ¿ estimated.Treatment/therapy start date - estimated.Date of implant ¿ estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effect of thrombosis/thrombus is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient-device incompatibility, thrombosis/thrombus, and serious injury/ illness/ impairment, and their relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attached article, titled ¿napkin ring formation in culotte stenting using current-generation drug-eluting stents in left main coronary artery bifurcation.".

• Brand Name: XIENCE ALPINE 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: 14881840
• MDR Text Key: 295114479
• Report Number: 2024168-2022-07125
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199394
• UDI-Public: 08717648199394
• 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
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1125300-38
• Device Catalogue Number: 1125300-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male