MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1500225-12

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.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 left main artery.A 2.25x12mm xience sierra stent delivery system (sds) was advanced; however, resistance was felt when advancing through the guiding catheter and also with the anatomy at the target lesion.The stent dislodged during deployment.Another unspecified stent was successfully deployed to crush the dislodged stent against the artery wall.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

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.The investigation determined the reported difficulties advancing and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement causing the reported difficulty to advance.Resistance was once again met with the anatomy causing the reported failure to advance.The device dislodged during deployment and was crushed against the artery wall with a second stent successfully.A conclusive cause for the reported stent dislodgement could not be determined; however, factors that may contribute to stent dislodgement include, but are not limited to, manufacturing damage, interaction with difficult anatomy, interaction with device accessories and inadvertent mishandling by user during dispenser removal.It should be noted that a clinical specialist reviewed the cine and concluded clinically it is not possible to include or exclude the cause of the first stent coming off of the delivery system.It looks as if the stent was stuck on the proximal portion of the previous stent and dislodged the stent.It was also thought that wire position was lost, and the stent was removed from the balloon due to the wire going through a strut.In conclusion from the images provided, we cannot confirm or deny product malfunction versus user error.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10290212
• MDR Text Key: 199299012
• Report Number: 2024168-2020-05935
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: 1500225-12
• Device Lot Number: 9110641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention