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

Catalog Number	1804225-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of pain, edema, headache 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 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.The additional xience skypoint stent referenced in b5 and d10 is captured under a separate medwatch #.Attachment: medwatch report #mw5148624.
Event or Problem Description
A medwatch was received which states: 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: mw5148623.Subsequent to receiving the medwatch form, additional information was provided: the non-abbott stent was implanted on may 23, 2023.The patient was hospitalized for one day on (b)(6) 2023 due to the symptoms.The symptoms have not resolved and the patient is receiving treatment for the allergic reaction symptoms.No additional information was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: 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: 18485741
• Report Number: 2024168-2024-00532
• Device Sequence Number: 19538304
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2026
• Device Catalogue Number: 1804225-12
• Device Lot Number: 3011941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X23 MM XIENCE SKYPOINT STENT; ONYX STENT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 79 KG