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

Catalog Number UNK RX PRIME

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

Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Perforation (2001); Thrombosis (2100)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The date of event was estimated.The date of implant was estimated.The device was not returned for evaluation.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 perforation, intimal dissection, thrombosis and myocardial infarction are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported perforation, intimal dissection, 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.Literature article title: "additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: results of the press trial".The udi number is unknown as the part and lot #s were not provided.The patient death(s) referenced are being reported on a separate medwatch report #.

Event Description

It was reported through a research article identifying xience prime that may be related to the following: death, dissection, perforation, myocardial infarction, stent thrombosis, and target vessel revascularization.Specific patient information is documented as unknown.Details are listed in the article, titled, "additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation: results of the press trial.".

• Brand Name: XIENCE PRIME 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10581289
• MDR Text Key: 208370647
• Report Number: 2024168-2020-07987
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 62 YR