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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 06/23/2011

Event Type  Injury  

Manufacturer Narrative

Age: average age, sex: majority sex, date of event and implant: estimated date.The stents remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported through a research article that the xience prime may be related to target vessel failure defined as cardiac death, myocardial infarction, ischemia, stent thrombosis, and target lesion revascularization.Specific patient information is documented as unknown.Details provided in the attached article titled: " everolimus eluting stents in patients with diabetes mellitus and chronic kidney disease: insights from the tuxedo trial¿.

Manufacturer Narrative

A2: average age.A3: majority sex.B3, d6: estimated date.D4: the udi is unknown because the part number and lot number were not provided.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 effect(s) of myocardial infarction, thrombosis, and ischemia are listed in the xience prime 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) of myocardial infarction, ischemia and thrombosis, and the relationship to the product, if any, cannot be determined.However, the 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.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.A2: average age a3: majority sex b3, d6: estimated date literature attached: " everolimus eluting stents in patients with diabetes mellitus and chronic kidney disease: insights from the tuxedo trial¿.

• 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
• MDR Report Key: 9856758
• MDR Text Key: 187028813
• Report Number: 2024168-2020-02666
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

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 Catalogue Number: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 07/20/2020
• Supplement Dates FDA Received: 04/08/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR