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

Model Number 1804225-12

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

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 of the reported lot did not indicate a lot specific quality issue.A cine was received and reviewed by an abbott vascular clinical specialist: the reviewer concluded that the spot images provided confirms that the 2.25x12mm xience skypoint des was deployed in the left main bifurcation.Although the incident report says that the stent dislodged there were no images confirming that or any images pointing to the potential reason for the dislodgement.Without additional imaging prior to stent deployment a probable root cause cannot be determined.A device malfunction cannot be confirmed via the images provided.In this case, it is likely that the stent delivery system (sds) interacted with challenging anatomy during advancement, as resistance was noted, resulting in the reported failure to advance.Further interaction with the challenging anatomy during removal, as resistance was again noted, likely resulted in the reported difficulty to remove.Factors that could contribute to a dislodged stent during use include, but are not limited to, patient¿s disease state, interaction with accessory devices, and/or patient¿s anatomical morphology.It is possible that the sds interacted with challenging anatomy during retraction, as resistance was noted, contributing to the reported stent dislodgement; however, this cannot be confirmed.Additionally, a balloon catheter was advanced and threaded into the dislodged stent.The stent was then implanted in the left main artery.The investigation determined the reported failure to advance, difficult to remove, and the subsequent treatments appear to be related to the operational context of the procedure.Additionally, the investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery.The xience skypoint des 2.25 x 12 rx stent delivery system (sds) failed to cross and during removal of the sds with resistance, the stent came off the delivery system balloon in the left main (lm), which was not the intended vessel.While the dislodged stent was in the lm, a balloon catheter was advanced and threaded into the dislodged stent.The stent was then implanted in the lm.There was no adverse patient sequela or clinically significant delay reported.A same size stent was then implanted in the intended lesion in the lad.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: 13958496
• MDR Text Key: 288280257
• Report Number: 2024168-2022-03383
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2023
• Device Model Number: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 1080941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 75 KG