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

Catalog Number	1125350-33
Health Effect - Clinical Codes	Angina (1710); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908)
Date of Event	11/17/2015
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.The reported patient effects of angina, hypersensitivity, and hypertension are listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use as known patient effects of coronary stenting procedures.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 with respect to the design, manufacture, or labeling of the device.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The additional xience alpine devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported by the patient that on (b)(6) 2015 a 3.0x18 mm xience alpine stent was implanted in the mid left anterior descending (lad) coronary artery and a 2.5x28 mm xience alpine stent was implanted in the second diagonal of the lad.On (b)(6) 2015 the patient returned with chest pain and high blood pressure.A 3.25x18 mm xience alpine stent was implanted in the obtuse marginal (om) artery and a 3.5x33 mm xience alpine was implanted in the proximal lad across the diseased segments into the previously placed stent.The patient has had several angiograms performed due to continued chest pain, one in in (b)(6) 2016, (date not specified for (b)(6)) and on (b)(6) 2016, angiograms have confirmed all four stents remain patent.Routine medication was given for angina and for hypertension.The patient is concerned that she is possibly allergic to the stents which could be causing the chest pain.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 6065124
• Report Number: 2024168-2016-07415
• Device Sequence Number: 360377
• Product Code: NIQ
• UDI-Device Identifier: 08717648199561
• UDI-Public: (01)08717648199561(17)180701(10)5062241
• Combination Product (Y/N): N
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

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: 07/01/2018
• Device Catalogue Number: 1125350-33
• Device Lot Number: 5062241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: XIENCE ALPINE (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 62