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

Catalog Number UNK XIENCE SKYPOINT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 12/26/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the circumflex (cx) artery.The access site was the right radial obtained with a 6french (f) sheath and a 6f 3.5 guide catheter and advanced to the left main.A versaturn guide wire was inserted and advanced without difficulty to the distal cx.An intravascular ultrasound (ivus) pullback was performed.A 3.0x12mm nc trek neo balloon dilatation catheter (bdc) was advanced and inflated to 15 atmospheres (atms) for 15 seconds, then 17 atms for 12 seconds then removed without difficulty.A 3.25x18mm xience skypoint stent delivery system (sds) was advanced and inflated to 15 atms for 15 seconds and then the sds was removed.A 4.0x12mm nc trek neo bdc was advanced and inflated to 12 atms for 15 seconds and 14 atms for 12 seconds for post dilatation per standard procedure.At this point a perforation was noted on angiography and a 3.5x15mm non-abbott covered stent was deployed at 3 atms for 15 seconds to treat the perforation.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was performed.

Manufacturer Narrative

D4: the udi is unknown because the part/lot number were not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of perforation is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears 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.

• 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: 18699969
• MDR Text Key: 335293043
• Report Number: 2024168-2024-01785
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE SKYPOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 6 FR XB 3.5 GUIDE CATHETER; 6 FRENCH SHEATH; VERSATURN GUIDE WIRE
• Patient Outcome(s): Required Intervention