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

Model Number 1550325-28

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Dizziness (2194); Stenosis (2263); Prolapse (2475)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of myocardial infarction, stenosis, thrombosis and hypotension are listed in the xience sierra everolimus eluting coronary stent systems instructions for use, as a known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Patient id (b)(6). It was reported that on (b)(6) 2019, the patient underwent a coronary stenting procedure to treat a lesion in the proximal right coronary artery (rca). A 3. 25 x 28 mm xience sierra stent was implanted without issue. On (b)(6) 2020, the patient presented to the emergency room with lightheadedness and stated they had been feeling weak and lightheaded since the stenting procedure. Additionally, blood pressure was low and cardiac enzymes were elevated. Myocardial infarction was diagnosed. Medications were administered. Cardiology was consulted and angiography was performed, revealing severe in-stent restenosis and thrombosis. Intravenous ultrasound (ivus) noted prolapsed calcific plaque through the stent struts. Revascularization was performed on (b)(6) 2020, with angioplasty, stent implantation and aspiration thrombectomy. The event resolved on (b)(6) 2020. No additional information was provided.

• Brand Name: XIENCE SIERRA
• 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: 9624121
• MDR Text Key: 178554396
• Report Number: 2024168-2020-00869
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/26/2020
• Device Model Number: 1550325-28
• Device Catalogue Number: 1550325-28
• Device Lot Number: 9041941
• 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: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2019
• 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: 01/23/2020 Patient Sequence Number: 1