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

Model Number	1125350-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Perforation (2001)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9884910
• Report Number: 2024168-2020-02969
• Device Sequence Number: 2750119
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1125350-18
• Device Catalogue Number: 1125350-18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 07/20/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 07/07/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR