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

Model Number 1804350-18

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified proximal left anterior descending artery that is 90% stenosed.The lesion was pre-dilated with a 3.0x12mm non-abbott balloon.A 3.5x18mm xience skypoint stent delivery system (sds) was attempted to be advanced; however, it was difficult to advance thru the distal tip of the guide catheter.An additional attempt was made to keep advancing, but was unsuccessful.The sds was removed; however, resistance was noted and the stent became dislodged.A 1.5mm unspecified balloon was used to attempt to move the stent into the guide catheter with the balloon inflated but failed.Additionally, the stent was attempted to be removed into a protective sheath via snare, but was unsuccessful.A cut down was performed at the femoral artery to remove the stent.A non-abbott stent was then used to successfully complete the procedure.There was no adverse patient sequela; however, a clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the delay to treatment/ therapy and subsequent treatments appear to be related to the operational context of the procedure.Additionally, the cause of the reported removal of foreign body was due to the dislodged stent in the anatomy.Factors that could contribute to a difficult to advance include, but are not limited to, inner diameter of guide wire lumen, outer diameter of the guide wire, patient¿s anatomical morphology, damage to the guide wire, damage to the catheter, and/or accumulation of procedural contaminants in the guide wire lumen.Factors that could contribute to a dislodged stent include, but not limited to, improper or inadequate crimping at the time of manufacture, forced sheath removal, handling of the stent during preparation, interaction with challenging anatomy, and/or interaction with accessory devices.Factors that could contribute to a difficult to remove include, but are not limited to, damage to the balloon, stent wall apposition, interaction with challenging anatomy, and/or interaction with accessory devices.In this case, it is possible that the stent delivery system (sds) interacted with the mildly calcified, mildly tortuous, and 90% stenosed lesion and/or guide catheter during advancement, resulting in the reported difficult to advance.Further interaction with the challenging anatomy and/or guide catheter during removal, as resistance was noted, possibly resulted in the reported difficult to remove and subsequent dislodged stent; however, this cannot be confirmed.Additionally, the stent was attempted to be removed into a protective sheath via snare but was unsuccessful.A cut down was performed at the femoral artery to remove the stent.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: 14359555
• MDR Text Key: 291409978
• Report Number: 2024168-2022-05147
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 110074A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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; Hospitalization