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

Catalog Number 1011708-33

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

Patient Problems Aneurysm (1708); Angina (1710); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/15/2021

Event Type  Death  

Manufacturer Narrative

Estimated date of death.Estimated date of event.Estimated date of implant.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effect of angina, aneurysm, occlusion and death are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.Literature attachment: article title "case series of coronary artery aneurysmsafter everolimus eluting stent implantation and comparison with sirolimus eluting stents ".

Event Description

It was reported that the patient presented with chest pain and angiography showed 90-95% stenosis in the mid left anterior descending (lad) coronary artery.The proximal lad was stented with a 3.75x33 mm xience prime stent and post dilatation was performed with a 3x12 mm traveler balloon dilatation catheter (bdc).The patient returned 3.5 months later with angina.Repeat angiography showed complete occlusion of the lad stent and three large aneurysms including one giant aneurysm adjacent to the entire length of the stent.A 3.5x19 mm graftmaster covered stent was used safely to approximate the aneurysm.The patient was scheduled for follow up but expired 10 days later due to heart failure.No additional information was provided.

• Brand Name: XIENCE PRIME LL 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 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13873810
• MDR Text Key: 287771624
• Report Number: 2024168-2022-03049
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1011708-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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
• Treatment: 3.5X19 MM GRAFTMASTER
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Male