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

Catalog Number 1804250-48

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous left anterior descending artery that is 90% stenosed.The 2.5x48mm xience skypoint stent delivery system failed to cross due to anatomy.Resistance was noted during removal with anatomy and once withdrawn the tip was observed to be bent.Pre-dilatation was performed with an unspecified balloon and a new xience skypoint was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, heavily tortuous and 90% stenosed anatomy resulting in the reported failure to advance and the reported difficult to remove.Interaction with the anatomy and/or manipulation of the device resulted in the reported deformation due to compressive stress (tip bend).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13476669
• MDR Text Key: 288790746
• Report Number: 2024168-2022-01255
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: 1804250-48
• Device Lot Number: 0111041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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