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

Model Number	1804400-28
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the mildly calcified tibial /popliteal trunk.The 4.0x28mm xience skypoint stent delivery system (sds) was advanced and deployed; however, it was believed the stent did not deploy as it was not visible on the xray.The sds was removed and the staff began to look for the stent outside the patient, but could not find the stent.Therefore, a ct scan was performed and noted the stent had migrate down below the knee.No intervention was made to remove the stent and remains free floating.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.User facility medwatch report received that states".Describe the event or problem: surgeon deployed a coronary stent to the lower leg (xience skypoint 4.0 mmx 28 mm).Upon review, they noticed that it is not visible on x-ray with c-arm.Charge nurse was made aware, inspected the catheter and packaging, as well as searched the room.Manager was made aware, and surgeon ordered for patient to go to ct for a full body ct scan after pacu (post anesthesia care unit).Package was saved for inspection.What was the original intended procedure? : ultrasound guided right femoral artery access right lower extremity arteriogram with selective third order catheterization.Right posterior tibial vein access with ultrasound guidance.Right angioplasty and stenting of peroneal artery and posterior tibial vein.Percutaneous transcatheter deep venous arterialization using pioneer ivus.Venoplasty of lateral plantar vein and dorsal veins.Intravascular ultrasound of posterior tibial vein.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working); additional information for patient #1 : other information about the patient that may have influenced the outcome of the event: final angiogram was performed.At this point it was noted that the coronary stent was no longer visible in the location of tpt where originally deployed.We then proceeded to image the right leg, pelvis, abdomen and chest to evaluate for migration given new arteriovenous connection.Although no evidence of migration out of leg, unclear therefore further imaging will be obtained.A 6fr mynx closure device was deployed in the femoral artery and addition pressure was held for hemostasis.Dermabond and steri strips were applied to groin access.The patient was transferred to recovery in stable condition.".
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 1494 clarifier - incorrect anatomy.Medwatch form (b)(4).
Additional 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.It was reported that the procedure was to treat the mildly calcified tibial /popliteal trunk.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) states: the xience skypoint stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions.In this case, it is unknown if the instruction for use (ifu) deviation related to off-label use (incorrect anatomy) contributed to the reported event; therefore, an in-service letter will not be requested.The investigation was unable to determine a conclusive cause for the reported visibility issue and stent migration.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
• Common Device Name: 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: 17129797
• Report Number: 2024168-2023-06266
• Device Sequence Number: 17972552
• Product Code: NIQ
• UDI-Device Identifier: 08717648233500
• UDI-Public: 08717648233500
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 1804400-28
• Device Catalogue Number: 1804400-28
• Device Lot Number: 2012141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown