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

Catalog Number 1009528-18

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

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199); Pericardial Effusion (3271)

Event Date 09/11/2020

Event Type  Death  

Manufacturer Narrative

The stent remains in the patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo right coronary artery (rca) that is 80% stenosed. The patient presented with an inferior wall st-elevation myocardial infarction and a 2. 75x18mm xience v was implanted. Post implantation, patient had a myocardial rupture. An emergency pericardiocentesis was performed; however; the rupture was too large. The patient experience hypotension and went into cardiac arrest. Patient died and no autopsy was performed. No additional information was provided.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• 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: 10652292
• MDR Text Key: 210505144
• Report Number: 2024168-2020-08396
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 1009528-18
• Device Lot Number: 0012941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/08/2020 Patient Sequence Number: 1