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 Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 11/30/2006

Event Type  Injury  

Manufacturer Narrative

Age: median age.Sex: majority.The device was implanted and will not return.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional patient effects and xience devices referenced are being filed under separate medwatch reports.Literature attached: ¿everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.¿.

Event Description

It was reported through a research article that the absorb scaffold and the xience v, xience prime, and xience xpedition stents may be related to thrombosis, target lesion failure (cardiac death, target vessel myocardial infarction, ischemia driven target lesion revascularization), myocardial infarction, death, and in device late lumen loss.Specific patient information is documented as unknown.Details provided in the attached article titled: " everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.¿.

Manufacturer Narrative

A2: median age.A3: majority.B3, d6: estimated.D4: 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.It should be noted that the reported patient effect(s) of stenosis, ischemia, myocardial infarction, and thrombosis are listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s) of stenosis, ischemia, myocardial infarction and thrombosis, 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.

• 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
• MDR Report Key: 10116838
• MDR Text Key: 193944110
• Report Number: 2024168-2020-04726
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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
• Date Manufacturer Received: 07/09/2020
• 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