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

Catalog Number 1125275-12

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

Patient Problem Ventricular Tachycardia (2132)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.The investigation was unable to determine a definitive cause for this incident.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Although a conclusive cause for the reported patient effect 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 Description

It was reported that the 2.75x12 xience alpine stent was implanted in the mid left anterior descending coronary artery on (b)(6) 2015.The patient was admitted to the hospital with ventricular tachycardia on an unknown date.No additional information.

Manufacturer Narrative

(b)(4).As the event was unrelated to the device and procedure, no investigation required.

Event Description

Subsequent to the previously filed report, the following additional information was received: on (b)(6) 2015 the patient developed chest discomfort with st elevation during a stress test.The patient also felt lightheaded and had a brief run of ventricular tachycardia.The patient was cardioverted one time.The chest x-ray, labs, cardiac enzymes and ekg were all negative for an acute event.Nitrate medication was administered.A cardioverter defibrillator was implanted on (b)(6) 2015.The condition resolved on (b)(6) 2015 and the patient was discharged home.There was no adverse patient sequela.The study site considered this event to be unrelated to the implanted study device and unrelated to the study procedure.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: 5089508
• MDR Text Key: 26227144
• Report Number: 2024168-2015-05441
• Device Sequence Number: 1
• Product Code: NIQ
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 11/03/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2017
• Device Catalogue Number: 1125275-12
• Device Lot Number: 4081841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 54 YR
• Patient Weight: 81