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

Catalog Number 1500350-18

Device Problems Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The 3. 5x12mm xience sierra device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a de novo, 80% stenosed, mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery. The 2. 5x33mm xience sierra stent was deployed in the distal lad and the 3. 5x18mm xience sierra was deployed in the proximal lad. A 3. 5x12mm xience sierra was implanted in between the first two stents as it was noted there was an uncovered area between the first two stents. A 5. 5x8mm non-compliant balloon was used to post dilate as standard practice to optimize the proximal segment and during this post dilatation, it was found that the 3. 5x18 mm xience sierra in the proximal lad separated and a part had moved to the aorta under angiography. The separated portion of the stent was deliberately flared as much as possible in the aorta to try and reduce the struts sticking out. There was no reported adverse patient sequela. There was no significant delay in the procedure.

• 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: 12885878
• MDR Text Key: 285986792
• Report Number: 2024168-2021-10849
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1500350-18
• Device Lot Number: 1070141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: 11/29/2021 Patient Sequence Number: 1

Treatment

2.5X33MM XIENCE SIERRA STENT; 3.5X12MM XIENCE SIERRA; 5.5X8 NC EMERGE BALLOON CATHETER