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

Catalog Number UNK XIENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 04/26/2015

Event Type  Injury  

Manufacturer Narrative

Event dates estimated.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of thrombosis and myocardial infarction is listed in the xience everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported thrombosis and myocardial infarction, 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.The udi is unknown as the part and lot numbers were not provided.Article attachment: title: comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.

Event Description

It was reported through a research article identifying a xience stent that was implanted in the proximal right coronary artery.The patient presented with a st elevated myocardial infarction (mi).Pre-dilatation was performed with an unspecified 3x15mm balloon at 10 atmospheres (atms), and the 3x12mm xience stent was implanted at 16 atms.Post-dilatation was not performed.The patient developed thrombosis and a mi 511 days later.Additionally, malposition was observed.Type of treatment was not specified.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of thrombosis and myocardial infarction are listed in the xience everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined a conclusive cause for the reported patient-device incompatibility wall apposition cannot be determined.A conclusive cause for the reported thrombosis and myocardial infarction, 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.H10: additional statement provided to address wall apposition.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: XIENCE 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: 10009235
• MDR Text Key: 190139503
• Report Number: 2024168-2020-03983
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• 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): Hospitalization; Required Intervention; Disability