MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT VASCULAR STENT XIENCE SKYPOINT 2.75MMX23MM RAPID EXCHANGE EVEROLIMUS ELUTING CORONARY; CORONARY DRUG-ELUTING STENT

Model Number 1804275-23

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Unspecified Eye / Vision Problem (4471); Swelling/ Edema (4577)

Event Date 10/23/2023

Event Type  Injury  

Event Description

I had two cardiac stents implanted on (b)(6) 2023, by dr.(b)(6) at (b)(6) hospital.The description of stents is as follows: stent xience skypoint 2.75mmx23mm rapid exchange everolimus eluting coronary, manufacturer abbott laboratories.Model number 1804275-23; lot number 110184b; description lad 2 (left anterior descending, type 2); stent xience skypoint 2.25mmx12mmrapid exchange everolimus eluting coronary, manufacturer abbott laboratories.Model number 1804225-12; lot number 3011941; description lad (left anterior descending).A few days after the procedure, i started getting swelling on my scalp.The swelling then progressively extended to eyes, face, ears, neck, chest, and hand, and to less extent on other parts of the body.I also feel swelling in internal organs like heart and lungs, etc.Later, i started getting headache, pain in my back and waist as well.I visited the er (emergency room) at (b)(6) on (b)(6) 2023, with severe swelling on my scalp, face, eyes and shoulders.I was prescribed prednisone, diphenhydramine and amoxicillin-clavulanate.I was advised to meet with my cardiologist and allergy specialist which i did.After completing the course of drugs prescribed by er, i started taking cetirizine 20 mg twice daily as recommended by dr.(b)(6) (allergy specialist).After two weeks of taking cetirizine 20 mg bd (twice per day), the swelling is reduced.However, i continue to have swelling occurring in different parts of the upper body at different times (it comes and goes in eyes, face, scalp, arms, ear lobes, thigh etc.).The pain in back and waist and headache continues.Due to swelling in eyes my vision is also impacted.Overall, this has adversely impacted my life.I also have another cardiac stent which was implanted on (b)(6) 2023.The description of the stent is as follows: stent coronary 3x26mm onyx frontier rx drug eluting.Model: onyxng30026ux; lot: 0011654032.Description: rca (right coronary artery).I did not get an allergic reaction after this stent was implanted.Reference report: mw5148624.

• Brand Name: STENT XIENCE SKYPOINT 2.75MMX23MM RAPID EXCHANGE EVEROLIMUS ELUTING CORONARY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT VASCULAR
• MDR Report Key: 18246009
• MDR Text Key: 329667435
• Report Number: MW5148623
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1804275-23
• Device Lot Number: 110184B
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG QD; ATORVASTATIN 40 MG QD; CETIRIZINE 20 MG BD (TWICE PER DAY); CLOPIDOGREL 75 MG QD; METOPROLOL SUCCINATE 25 MG QD (EVERY DAY); MULTIVITAMIN; STENT CORONARY 3X26MM ONYX FRONTIER RX DRUG ELUTING
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian