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

Catalog Number 1120400-18

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Hypersensitivity is listed in the xience alpine eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The other device is being filed under a separate medwatch report.

Event Description

It was reported that the patient presented with segment elevated myocardial infarction (stemi) on (b)(6) 2016.The procedure was to treat a lesion located in an unspecified vessel.Two stents were implanted: 3.5x38mm xience alpine and a 4x18mm xience alpine.On (b)(6) 2016 the patient returned for a scheduled controlled angiogram which showed good results.The patient was having an allergic reaction and the patient was symptomatic with peeling of hands, peeling of the soles of his feet, and localized itching.The exact date when the symptoms began was unknown.On (b)(6) 2016 during a post procedure checkup the cardiologist noted itchiness on the patients back.Medical treatment for the patients symptoms included cortisone cream.It is unknown if allergy testing was performed and if the patient had an allergy to either medication or to the metal.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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6191330
• MDR Text Key: 62910449
• Report Number: 2024168-2016-09058
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205897
• UDI-Public: (01)08717648205897
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1120400-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: STENT: 3.5X38 XIENCE ALPINE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 36