MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT SCIENCE SKYPOINT 38MM; CORONARY DRUG-ELUTING STENT

Catalog Number 1804350-38

Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2022

Event Type  Injury  

Event Description

During the procedure, it was decided to pull back the xience skypoint 3.5 mm x 38 mm coronary stent to relocate.No angioplasty had been conducted.During the process of retracting the stent, the stent apparently released from the balloon, possibly due to a defective stent or the stent got caught in calcium or prior stent; etiology unk.

• Brand Name: ABBOTT SCIENCE SKYPOINT 38MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 16043500
• MDR Text Key: 306273061
• Report Number: MW5113986
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1804350-38
• Device Lot Number: 2043041
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 57 KG