MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT; CORONARY DRUG-ELUTING STENT

Model Number 1804350-23

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Product came out of package damaged and unusable.No patient contact; no harm.New product opened to complete the procedure.Manufacturer response for xience skypoint 3.5x23mm, (brand not provided) (per site reporter).

• Brand Name: XIENCE SKYPOINT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 13901186
• MDR Text Key: 287915594
• Report Number: 13901186
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 1082541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male