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

Catalog Number 1804300-18

Device Problems Material Rupture (1546); Difficult to Advance (2920)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous mid left anterior descending artery that is 90% stenosed.After ablation a non-abbott 2.75x15mm balloon was used to additionally dilate the lesion.The 3.0x18mm xience skypoint stent delivery system (sds) was advanced to the lesion and resistance was noted with the anatomy.During an attempt to deploy, the balloon ruptured at 5 atmospheres.The stent was not deployed; therefore, the sds was removed.Another 2.75x15mm non-abbott balloon was used to dilate the lesion again, a non-abbott stent was implanted and 3.0x15mm non-abbot balloon was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.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: 17614507
• MDR Text Key: 322485567
• Report Number: 2024168-2023-09255
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2023

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 Catalogue Number: 1804300-18
• Device Lot Number: 2081741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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