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

Model Number 1550350-23

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

Patient Problems Intimal Dissection (1333); Angina (1710); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Prolapse (2475)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient id: (b)(6). It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi), elevated cardiac enzymes, and a proximal circumflex (cx), 95% stenosed lesion. A percutaneous coronary intervention was performed. Pre-dilatation was performed on the cx lesion and a 3. 5x23mm xience sierra stent (1550350-23, 9120941) stent was implanted with acceptable results. Post-implantation, a proximal edge dissection was observed. As treatment, a 2. 5x38mm xience sierra stent (1550250-38, 90100341) and a 4. 0x8mm xience sierra stent (1550400-08, 0051241) were implanted. Post-procedure imaging was performed with intra-stent plaque protrusion or thrombus, and dissection, unknown if this was the same previous dissection, were observed. The stent was not specified in this case. On (b)(6) 2020, the patient was admitted to the hospital with chest pain. Elevated cardiac enzymes were observed and a new myocardial infarction (mi) was diagnosed. As treatment, another pci was performed within the 50% occluded, proximal cx. The event resolved without sequela. Reportedly, there was no device malfunction. No additional information was provided regarding this issue.

• 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: 10690943
• MDR Text Key: 211916956
• Report Number: 2024168-2020-08661
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/12/2020
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 9120941
• 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: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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: 10/16/2020 Patient Sequence Number: 1