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

Catalog Number UNK XIENCE

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

Patient Problem Stenosis (2263)

Event Date 01/23/2022

Event Type  Injury  

Event Description

It was reported via an article, in-stent restenosis (isr) occurred after implantation of a xience stent; the implant date was not provided, estimated date is (b)(6) 2010.On (b)(6) 2022 (estimated date), a sirolimus-eluting magnesium bioresorbable scaffold (mgs) was implanted for treatment of the isr.Details are listed in the attached article, titled ¿treatment of in-stent restenosis with sirolimus-eluting magnesium bioresorbable scaffolds: optical coherence tomography insights.¿.

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review for this product was not performed since the part/lot numbers were not reported.A conclusive cause for the reported stenosis, and the relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention and hospitalization / prolonged hospitalization appear to be related to the operational context of the procedure.The reported patient effect of stenosis is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Date of event estimated: (b)(6) 2022.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Literature attachment.Article title ¿treatment of in-stent restenosis with sirolimus-eluting magnesium bioresorbable scaffolds: optical coherence tomography insights¿.

• 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
• 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: 15340603
• MDR Text Key: 299142067
• Report Number: 2024168-2022-09329
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P070015
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male