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

Model Number 1804300-18

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

During inventory clearance of the hospital it was noted that a 3.0x18mm xience skypoint had a different lot number between the manufacturing label and the (b)(6) label of the xience skypoint.The device was not unpacked and not used.The manufacturing label has lot number 0090841 and the (b)(6) label has 0090741.There was no patient involvement and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported labeling problem was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported labeling issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The xience skypoint device is not currently commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that during inventory clearance of the hospital it was noted that a 3.0x18mm xience skypoint had a different lot number between the manufacturing label and the japanese label of the xience skypoint.The device was not unpacked and not used.The manufacturing label has lot number 0090841 and the japanese label has 0090741.There was no patient involvement and no clinically significant delay.No additional information was provided.Based on re-review of this event, this event would not have been reportable because the device marking/labeling issue of lot # does not impact the use of the device and there is no potential for a serious injury.However, since the initial report has already been filed, this event must remain reportable.

• 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
• MDR Report Key: 11679617
• MDR Text Key: 245825982
• Report Number: 2024168-2021-03221
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233241
• UDI-Public: 08717648233241
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

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 Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 1804300-18
• Device Catalogue Number: 1804300-18
• Device Lot Number: 0090841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1