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

Catalog Number UNK RX PRIME

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Prolapse (2475); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 04/01/2014

Event Type  Injury  

Manufacturer Narrative

Attached article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs.Stable coronary artery disease." event date: the date of occurrence is estimated.Udi: the udi number is ¿ni¿ as the catalog number was not provided.The xience xpedition is filed under a separate medwatch report number.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 part and lot numbers were not provided.The reported patient effects of thrombosis and dissection are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.Based on the information reviewed, a conclusive cause for the reported wall apposition and patient effects could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

The study investigated vascular response occurring at 3 months after xience prime and xience xpedition everolimus-eluting cobalt-chromium stent implantation in patients with st-segment elevation myocardial infarction versus stable coronary artery disease.The following complications were noted: uncovered stent struts and mal-apposed stent struts related to intrastent thrombus, irregular protrusion and edge dissection.Specific patient information is documented as unknown as this is from an article summary.Details are listed in the attached article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs.Stable coronary artery disease.".

• Brand Name: XIENCE PRIME 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: 13831420
• MDR Text Key: 287577154
• Report Number: 2024168-2022-02881
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• 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: 66 YR
• Patient Sex: Female