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

Model Number 1550300-23

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

Patient Problems Angina (1710); Vasoconstriction (2126)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as the stent remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina and vasoconstriction (coronary artery spasm) are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional device (3.0x8 mm xience sierra) referenced is being filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020 two xience sierra stents (3.0x8, 3.0x23) were implanted in the first diagonal (d1) coronary artery.On (b)(6) 2020 the patient had chest pain.The stent was patent, but both stents were pinching the left anterior descending (lad) coronary artery.According to the physician, this was not an occlusion.Angioplasty was performed with a kissing balloon technique to the lad and d1.The patient had good results and the condition resolved the same day.No additional information was provided.

• 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: 10557121
• MDR Text Key: 207714621
• Report Number: 2024168-2020-07839
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Device Lot Number: 0021241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60