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

Model Number	1804400-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).The 4.0x18mm xience skypoint stent was implanted on (b)(6) 2023.On (b)(6) 2023, the patient complained of itchy hands and feet, flushing, and hives.He took zyrtec and benadryl and the symptoms subsided for a day.The following day, (b)(6) 2023, he experienced hiccups that lasted all day long, and difficulty swallowing due to pressure and pain in his throat.Eating and drinking liquids was difficult due to the pain in his throat.He went to urgent care where a computed tomography (ct) scan was performed which showed irritation of the chest and inflammation around the heart.The physician could not explain anything and suggested he follow up with his primary care physician.He followed up with his primary care physician; however, an endoscopy procedure could not be performed due to the discomfort in his throat.He then started to feel immense pain in his joints and could not walk.He consulted with a rheumatologist and blood work was performed which showed inflammatory markers were elevated.He was prescribed prednisone for the joint pain.The joint pain was better by (b)(6) 2023.He then saw a gastroenterologist who did not find anything to be a cause of the inflammation or pain/swelling in the throat.He was then admitted into the hospital on (b)(6) 2023 due to the throat pain/swelling and diarrhea.He was administered medication and iv liquids however he started experiencing burning of the mouth and skin sensitivity.The only known allergies are to niacin, which he had similar reactions to.The patient is still in the hospital.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of pain, edema and hypersensitivity are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic 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; however, the reported treatments appear 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
• 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: 16881363
• Report Number: 2024168-2023-04807
• Device Sequence Number: 5717862
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: 01/18/2026
• Device Model Number: 1804400-18
• Device Catalogue Number: 1804400-18
• Device Lot Number: 3012441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG