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

Catalog Number UNK XIENCE PROA

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

Patient Problems Angina (1710); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of hypertension, angina, pain and hypersensitivity are listed in the xience pro a everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the 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.

Event Description

It was reported that in 2018, a xience pro a stent, and a non-abbott stent were implanted.Months after the implantation of the stents, the patient developed hypertension, headache, chest pain, pain in the shoulder joint and pain in the cervical spine.The patient¿s cardiologist assumed that the symptoms could be triggered by a metal allergy.No additional information was provided.

• Brand Name: XIENCE PROA 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: 13588959
• MDR Text Key: 286642890
• Report Number: 2024168-2022-01957
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE PROA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• 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
• Treatment: BOSTON SCIENTIFIC SYNERGY STENT
• Patient Outcome(s): Other
• Patient Sex: Female