MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550225-18

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a 75% stenosed, moderately calcified lesion in the mildly tortuous distal right coronary artery. Following pre-dilatation, the 2. 25 x 18 mm xience sierra stent was advanced without resistance and deployed. The stent balloon was dilated twice at 12 atmospheres. It was seen on the angiography that contrast was leaking from the balloon during the third inflation at 16 atmospheres. The stent was deployed without issue and apposition was confirmed with intravascular ultrasound (ivus) and the procedure was completed. No resistance was felt with the balloon during removal. The stent balloon was dilated outside the anatomy and a leak was observed. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8187805
• MDR Text Key: 131341975
• Report Number: 2024168-2018-09975
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/10/2021
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8032341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial