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

Catalog Number UNK RX XIENCE

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

(udi#): in the absence of a reported part number, the udi cannot be calculated.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature article title: ¿safety and efficacy of second-generation drug-eluting stents in real-world practice: insights from the multicenter grand-des registry.

Event Description

It was reported through a research article/presentation identifying xience stents that may be related to: myocardial infraction, thrombosis, hemorrhage, prolonged hospitalization, and surgical intervention.Specific patient information is documented as unknown.Details are listed in the article, titled ¿safety and efficacy of second-generation drug-eluting stents in real-world practice: insights from the multicenter grand-des registry." no additional information was provided.

Manufacturer Narrative

The udi is unknown because the part number and lot number were not provided.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 numbers were not provided.A conclusive cause for the reported patient effects of myocardial infarction, hemorrhage, and thrombosis, and the relationship to the product, if any, cannot be determined.The reported patient effects of myocardial infarction and thrombosis are listed in the xience v everolimus eluting coronary instructions for use as known possible complications associated with mitraclip procedures.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE V 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: 10489189
• MDR Text Key: 205536522
• Report Number: 2024168-2020-07362
• 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
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XIENCE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability