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

Model Number 1550325-38

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

Patient Problems Cardiac Enzyme Elevation (1838); Occlusion (1984); Prolapse (2475)

Event Date 02/10/2020

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 prolapse and occlusion are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 of the device.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020 three xience sierra stents, sizes 3.25x38, 3.5x38, and 4.0x38 mm, were implanted in the distal right coronary artery (dist rca).When the most distal stent, the 3.25x38, was implanted, occlusion/ plaque shift occurred into the right posterior descending coronary artery.This was treated with balloon angioplasty with a 2.0 mm balloon dilatation catheter advanced through the 3.25 stent struts.The condition resolved.There was no adverse sequela.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: 9785776
• MDR Text Key: 181974980
• Report Number: 2024168-2020-01983
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227387
• UDI-Public: 08717648227387
• 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: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 1550325-38
• Device Catalogue Number: 1550325-38
• Device Lot Number: 9051541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA STENTS: 3.5X38, 4.0X38 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 95