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

Model Number 1804350-28

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 identified no other incidents from this lot.It was reported that the stent delivery system (sds) was attempted to be deployed distal to a previously implanted stent.It should be noted that the xience skypoint instructions for use states, when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.In this case, it is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; additionally, the reported foreign body in patient was due to a stent dislodgement within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately tortuous right coronary artery.Pre-dilatation was performed.Then a 3.5x28mm xience skypoint stent was advanced through a previously implanted stent with no resistance but was unable to further cross through the distal lesion.It was decided to pullback the stent implant and resistance was felt against the previously proximal implanted stent.The physician noticed the xience stent implant had slipped off the balloon about 1/3 so it was decided to implant it at that point in the vessel.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: 15005500
• MDR Text Key: 295857473
• Report Number: 2024168-2022-07641
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: 08717648233425
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 2022841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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
• Patient Outcome(s): Other