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

Catalog Number 1128400-12

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The reported patient effect of hypersensitivity is listed in the xience pro a/alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.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 effect(s), and the relationship to the product, if any, cannot be determined; however, the reported 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 of the device.The xience proa is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The additional six xience alpine referenced are being filed under separate medwatch report numbers.

Event Description

It was reported that on (b)(6) 2018 a 2.75x28mm, 3.0x18mm, 2.5x18mm, and a 3.0x18mm xience alpine stents were deployed without issues.On (b)(6) 2020, a 3.0x23mm and a 4.0x38mm xience alpine stents and a 4.0x12mm xience proa stent were deployed without issues.On (b)(6) 2020, the patient was re-admitted with unspecified health issues.Coronary bypass surgery was going to be performed; however, it was canceled because the patient was diagnosed with a suspicion of kounis syndrome due to an allergic reaction.Explanting the stents is being contemplated.There has been no treatment for the allergic reaction.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: 11158713
• MDR Text Key: 226542602
• Report Number: 2024168-2021-00377
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: 1128400-12
• Device Lot Number: 7112441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: 2.5X18MM XIENCE ALPINE; STENT: 2.75X28MM XIENCE ALPINE; STENT: 3.0X18MM XIENCE ALPINE; STENT: 3.0X18MM XIENCE ALPINE; STENT: 3.0X23MM XIENCE ALPINE; STENT: 4.0X38MM XIENCE ALPINE
• Patient Outcome(s): Hospitalization