MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1125350-18

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

Patient Problems Angina (1710); Perforation (2001)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: estimated dates.The device will not be returned for evaluation as the stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The graftmaster referenced is being filed under a separate medwatch report.

Event Description

It was reported in a literature article that the 3.5x18 mm xience alpine stent was implanted and a perforation was noted.Prolonged balloon inflation was performed, but did not achieve hemostasis.This was followed by the placement of the 3.5x19 mm graftmaster implanted inside the xience stent; this successfully treated the perforation and stopped the bleeding.The chest pain resolved and the patient was discharged home two days post procedure.Six months later, the effort angina returned; angiogram found a focal restenosis on the distal edge of the graftmaster.Pci was performed using oct and angiogram.Oct found extremely focal restenosis with homogeneous neointima.There were exposed struts in the middle and proximal segment of the graftmaster stent.There was no thrombus found.Restenosis was treated with the implantation of a 3.0x9 mm non-abbott, biodegradable sirolimus-eluting stent.Six months later, the patient had angina again.There was stenosis in the non-abbott stent.This was treated with balloon angioplasty using a 3.0x20 mm drug-coated balloon.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of perforation and angina are listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

C4: estimated date this report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9884910
• MDR Text Key: 188402085
• Report Number: 2024168-2020-02969
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1125350-18
• Device Catalogue Number: 1125350-18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR