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

Catalog Number UNK RX SIERRA

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Prolapse (2475)

Event Date 02/01/2020

Event Type  Injury  

Event Description

The study investigated strut coverage comparison between non-abbott orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (o-ses) and xience alpine and xience sierra everolimus-eluting stents (x-ees), using the dragonfly catheter optical coherence tomography (oct), eight months post implantation.The following complications were noted: uncovered stent struts and mal-apposed stent struts and irregular protrusion.A few patients were excluded from the study due to poor quality images with the dragonfly.The study concluded o-ses showed higher percentage of the covered struts compared to x-eess, at eight month oct follow-up.Specific patient information is documented as unknown as this is from an article summary.Details are listed in the attached article, titled "preferable vascular healing of ultrathin strut biodegradable polymer sirolimus eluting stents in patients with acute coronary syndrome.".

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 and similar incident query for this product was not performed since the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility and prolapse; however, the subsequent serious injury/ illness/ impairment appears to be related to the operational context of the procedure.The reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect 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) 2020.The udi is unknown due to the part/lot number was not provided.Implant date estimated: (b)(6) 2019.Literature attachment.Article title: preferable vascular healing of ultrathin strut biodegradable-polymer sirolimus-eluting stents in patients with acute coronary syndrome.The xience alpine device referenced is filed under a separate medwatch report number.

• Brand Name: XIENCE SIERRA 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: 15536502
• MDR Text Key: 301098871
• Report Number: 2024168-2022-10265
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX SIERRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Male