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

Model Number	1074300-33
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)
Date of Event	12/05/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code 1494/patient selection.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 effect of hypersensitivity reaction is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.0x33mm xience xpedition stent delivery system (sds) was implanted on (b)(6) 2014.An allergic reaction occurred as the patient noticed shortness of breath but had no other adverse reactions.The patient thought this was somewhat normal as the patient is allergic to things like nickel, latex, bees, and stitches among other things.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states: the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent system are contraindicated for use in patients with known hypersensitivity or contraindication to everolimus, cobult, chronium, nickel, tungsten, acrylic, and fluoropolymers.In this case, it is possible the ifu deviation related to use in patients with known hypersensitivity may have caused/contributed to the reported patient effects; however, this cannot be confirmed.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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.0x33mm xience xpedition stent delivery system (sds) was implanted on (b)(6) 2014.An allergic reaction occurred as the patient noticed shortness of breath but had no other adverse reactions.The patient thought this is somewhat normal as the patient is allergic to things like nickel, latex, bees, stitches, and among other things.Treatment, if any, was not reported.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT 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: 16853440
• Report Number: 2024168-2023-04563
• Device Sequence Number: 7658996
• Product Code: NIQ
• UDI-Device Identifier: 08717648162374
• UDI-Public: 08717648162374
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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: 05/06/2016
• Device Model Number: 1074300-33
• Device Catalogue Number: 1074300-33
• Device Lot Number: 4042941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2014
• 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: BOSTON SCIENTIFIC STENT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: White