MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE SKYPOINT

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 03/25/2023

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated as 3/25/2023.D4: the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch reports #mw5149000 and mw5149001.

Event Description

User facility medwatch reports (mw5149000 and mw5149001) received stating: on date above had major heart attack with stent placed.15 days later had another heart attack & another stent placed which was 90% blocked at the time of my first heart attack.(b)(6) 2023 they put me on brilinta.I got a rash that looked like sun poisoning almost immediately also swelling across my nose with lots of snot going down my throat & my throat closing/swelling up.Now here eight months later the "rash" is extreme & has overtaken my whole body almost.It just started out on one of my forearms.On (b)(6) 2023 doctors added norvasc to my medications & and that's when we noticed the rash became unbearable.It's still going on and not really healing up.But some doctors seen have acted very concerned and some have acted like it's no big deal.Reference report: mw5149000.No additional information was provided.

Manufacturer Narrative

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 occlusion, edema and hypersensitivity are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 18536312
• MDR Text Key: 333152517
• Report Number: 2024168-2024-00957
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE SKYPOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• 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): Hospitalization; Required Intervention