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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

Estimated date of event and implant.There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The reported patient effect of hypersensitivity is listed in the electronic instructions for use everolimus eluting coronary stent systems xience proa ce (ifu) as a known patient effect of coronary stenting procedures.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The xience proa device is currently not commercially available; however, it is similar to a device sold in the u.S.

Event Description

It was reported that in (b)(6) 2020 the xience pro a stent was implanted in the mid left circumflex coronary artery.One to three days after the stent procedure, the patient had trugiformis eczema.The dermatologist reported that the eczema may be related to the xience pro a stent as the patient has an intolerance to cobalt chromium.The patient was admitted to the hospital and was treated with medication.The patient has been discharged from the hospital, but the condition is ongoing.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: 10730330
• MDR Text Key: 213008173
• Report Number: 2024168-2020-08877
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention