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

Model Number 1550250-18

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Thrombosis (2100)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficult or delayed activation (difficulty to deploy); however, factors that may contribute to difficulty to deploy include but are not limited to damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation technique, contrast dilution, and inadequate connection to the inflation device.The reported patient effect of thrombosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The reported patient effect of thrombosis and the reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a 99% stenosed lesion in the mid left anterior descending artery (lad).On (b)(6) 2020, the patient presented with st-elevation myocardial infarction.Following pre-dilatation, a 2.5x18mm xience sierra stent was deployed; however, the stent was undersized for the vessel diameter and looked under expanded/irregular.No post-dilatation was performed, and the procedure was completed.On (b)(6) 2020, the patient went back to the cath lab due to the lad being occluded.An angiogram was performed and confirmed the occlusion to be thrombosis.The lesion was dilated, and the flow was restored.The patient is doing well.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: 9831258
• MDR Text Key: 186123818
• Report Number: 2024168-2020-02408
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227103
• UDI-Public: 08717648227103
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1550250-18
• Device Catalogue Number: 1550250-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• 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: 68 YR