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

Model Number 1804300-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/difficulty deploying the stent; however, the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a thrombotic, non-calcified mid left anterior descending artery.A 3x23mm xience skypoint stent was advanced to the lesion without issue.When attempting to implant the stent the vessel pushed it back to a more recoiled position.Additional post-dilatation was performed and an additional unspecified stent was implanted overlapping.There were no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 12319379
• MDR Text Key: 266563453
• Report Number: 2024168-2021-07142
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• 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: 08/13/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 119