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

Catalog Number 1500300-38

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

Patient Problems Bradycardia (1751); Cardiogenic Shock (2262); Respiratory Failure (2484); Vascular Dissection (3160)

Event Date 04/28/2021

Event Type  Death  

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 death and dissection are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as 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.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous de novo left anterior descending artery (lad), left circumflex (lcx) and the left main (lm).Five xience sierra stents were implanted (2.25x23 mm, 2.75x28 mm, 3.0x38 mm, 2.75x28 mm and 3.0x18 mm).Complications were noted during final dilatation in the left main artery.The patient went into bradycardia and cardiogenic shock and was intubated and transferred to the intensive care unit.It is assumed that a dissection from the lcx caused the complications.The patient expired and a clinically significant delay was reported.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: 11859565
• MDR Text Key: 251817920
• Report Number: 2024168-2021-04272
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2023
• Device Catalogue Number: 1500300-38
• Device Lot Number: 0121441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.25X23 XIENCE SIERRA; 2.75X28 MM XIENCE SIERRA; 2.75X28 MM XIENCE SIERRA; 3.0X18 MM XIENCE SIERRA
• Patient Outcome(s): Death