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

Catalog Number 1508300-15

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat an unspecified artery. The 3. 0x15mm xience pros stent was successfully implanted with no resistance during advancement. However, during implantation, it was noted that the pressure in the balloon which was inflated once with a pressure of 14 atmospheres (atms) was not maintained during dilatation. The stent was post dilated with a nc balloon because of the unsafe expansion of the stent and the inflation pressure during stent implantation that was not safely maintained. After removal of the balloon and upon inspection, it was noticed that there was a small hole from which the contrast medium could escape. The device was not prepped (air aspiration) outside the anatomy prior to use. There was no reported adverse patient effect and there was no clinically significant delay in the procedure. No additional information are required.

Manufacturer Narrative

The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. Device code: 2017 clarifier, incorrect prep. The xience pros device is currently not commercially available in the us; however, it is similar to a device sold in the usa.

• Brand Name: XIENCE PROS 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: 14142219
• MDR Text Key: 289511148
• Report Number: 2024168-2022-04189
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1508300-15
• Device Lot Number: 1100441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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: 04/19/2022 Patient Sequence Number: 1