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

Model Number 1125350-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/26/2017

Event Type  Injury  

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 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 hypersensitivity is listed in xience alpine 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 xience alpines (3.5 x 28 and 3.0 x 38) referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure the patient underwent was to treat an unspecified coronary artery.Three xience alpine stents were implanted on (b)(6) 2017: 3.5 x 28 mm, 3.0 x 38 mm and 3.5 x 18 mm.Approximately 2-3 days post stenting procedure, the patient began experiencing hives, rashes, itching and bruising (from scratching) all over her body and was re-hospitalized on (b)(6) 2017 due to her symptoms.The patient was released from the hospital on (b)(6) 2017.She has seen 4 specialists (cardiologist, internist, dermatologist and allergist), and it was thought that the adverse reaction is likely due to the drug (everolimus) on these stents.The patient has no medical history of allergies.She underwent a stenting procedure approximately 8 years ago, with implantation of one stent; the patient did not experience any adverse effects afterwards.The dosage of her medications have been increased.She was prescribed epifoam and vistaril, as well as prednisone.Her physician originally prescribed plavix; this was changed to brilinta.The brilinita was then changed to effient, which continues.Before the three xience alpine implants, the patient was taking baby aspirin but this was discontinued after the procedure.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6699151
• MDR Text Key: 79570983
• Report Number: 2024168-2017-05748
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: (01)08717648199530(17)190608(10)6060141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: 1125350-18
• Device Catalogue Number: 1125350-18
• Device Lot Number: 6060141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 79