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

Catalog Number 1120350-23

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

Patient Problems Atrial Fibrillation (1729); Myocardial Infarction (1969); Occlusion (1984); Heart Failure (2206)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: scaffold: 3.0 x 28 mm absorb gt1, guide catheter: 6f xb 3.0.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, atrial arrhythmias, myocardial infarction, occlusion, and congestive heart failure are listed in the instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.0 x 28 mm absorb gt1 referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a lesion located in the mid to distal left anterior descending artery (lad).Pre-dilatation was performed with a 3.0 x 20 mm balloon catheter.The 3.0 x 28 mm absorb gt1 scaffold delivery system was advanced; however, it would not cross distally; therefore, the scaffold was deployed in the diseased mid lad.The distal section was treated with a 2.75 x 28 mm xience alpine stent.When optical coherence tomography was performed a large calcified nodule was observed which was distorting the struts of the scaffold; therefore, the decision was made to deploy a 3.5 x 23 mm xience alpine to cover the distorted struts.This caused an occlusion of the diagonal branch which led to the patient experiencing a myocardial infarction.No treatment was performed for the diagonal occlusion as the vessel could not be rewired.Five (5) days later the patient experienced symptoms of atrial fibrillation and congestive cardiac failure.No additional information was provided.

Manufacturer Narrative

(b)(4).

• 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: 6350466
• MDR Text Key: 68059296
• Report Number: 2024168-2017-01438
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205828
• UDI-Public: (01)08717648205828
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/22/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 1120350-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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
• Patient Outcome(s): Hospitalization; Disability