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

Catalog Number 1804400-23

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Perforation of Vessels (2135)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that procedure was to treat a lesion in proximal left anterior descending (plad) artery with heavy calcification.The 4x23mm xience skypoint stent delivery system (sds) was advance to the target lesion and the stent was implanted.The stent was noted to be narrower in the center.Therefore, a balloon was used for post dilatation.After balloon dilatation a perforation was noted.Therefore, a nc trek balloon was used to attempted to treat the perforation; however, was not successful.The perforation was treated with implantation of a non-abbott stent.There was no adverse patient sequela.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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported wall apposition.The reported treatment appears to be related to operational context of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effect of a perforation is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.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: 18859533
• MDR Text Key: 337145792
• Report Number: 2024168-2024-02930
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233494
• UDI-Public: 08717648233494
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804400-23
• Device Lot Number: 3092541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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
• Treatment: CSI SCOREFLEX BALLOON
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White