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

Model Number 1550225-23

Device Problem Break (1069)

Patient Problems Perforation (2001); Stenosis (2263)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of stenosis and perforation are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported stent break; however, factors that may contribute to stent break include, but are not limited to, improper or incorrect method, interactions with other devices or interaction with lesion calcification and tortuosity.The reported patient effects of stenosis, perforation, additional therapy/non-surgical treatment, and hospitalization appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The two additional xience sierra stents are being filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was performed to treat a lesion in the circumflex artery.On (b)(6) 2019, a 2.25x12mm (distal), 2.25x23mm (middle), and 2.50x28mm (proximal) xience sierra stents were deployed.On (b)(6) 2020, the patient was re-admitted for in-stent restenosis.Ballooning was performed to treat the stenosis; however, while ballooning the 2.25x23mm implanted stent, the stent fractured.A 2.5x15mm non-abbott stent was deployed to treat the fracture, but this caused a perforation.A second non-abbott stent was used to successfully treat the perforation.There were no adverse patient sequela and no clinically significant delay in the procedure.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; cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9717897
• MDR Text Key: 180098304
• Report Number: 2024168-2020-01546
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227035
• UDI-Public: 08717648227035
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1550225-23
• Device Catalogue Number: 1550225-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 100