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

Model Number 1804400-12

Device Problems Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.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 performed to treat a lesion in the heavily tortuous and calcified mid to distal right coronary artery (rca).The first xience skypoint stent delivery system was advanced to the target lesion; however, the device was unable to cross to the target lesion due to the patient anatomy.The device was removed from the anatomy without difficulty and a second xience skypont was used.The second xience skypoint was advanced; however, this one was also unable to cross due to the patient anatomy and the proximal shaft kinked.The device was removed without difficulty, but separated at the kink, at a location outside the patient anatomy.Both separated segments were easily removed from the patient anatomy.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress (shaft kink) and material separation were confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.Additionally, biological matter was noted at the separated portion of the hypotube during return analysis of the device.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily tortuous and calcified artery causing the reported failure to advance.Continued resistance with the difficult anatomy during the attempted advancement ultimately resulted in a shaft kink and subsequent material separation.Additionally, regarding the noted biological matter at the separated portion of the hypotube, the account indicated that no patient injury was noted and no additional intervention was performed to treat patient injury.It is suspected that the tissue is due to advancing through the patient anatomy; however, this cannot be confirmed.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: 14782446
• MDR Text Key: 295486278
• Report Number: 2024168-2022-06737
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233463
• UDI-Public: 08717648233463
• 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,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: 1804400-12
• Device Catalogue Number: 1804400-12
• Device Lot Number: 1031042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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