MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1009541-15
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.It should be noted that the reported patient effects of hypersensitivity and rash are listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.Based on the information received, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on 04/20/2010 a 3.0x15 mm xience v stent was implanted in the right coronary artery.On an unspecified date, sometime in (b)(6) 2017, after eating pork and beef the patient began to experience swelling of the chin and chest.The patient then broke into a rash in the stomach, leg and face.The patient saw an allergist which informed him he was having an allergic reaction.Creams were given to the patient and he was informed to discontinue eating pork and beef.The patient was informed he is allergic to gold among other things (not specified) and was concerned he may be allergic to the stent.The patient is doing great.No additional information was provided.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7050488
• Report Number: 2024168-2017-09117
• Device Sequence Number: 16423678
• Product Code: NIQ
• UDI-Device Identifier: 08717648064098
• UDI-Public: 08717648064098
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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 Catalogue Number: 1009541-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 73