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

Catalog Number 1500350-18

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Stretched (1601); Failure to Advance (2524); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

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 to treat a severely stenosed lesion in left main (lm), left anterior descending (lad) and left circumflex (lcx) coronary artery.The 3.50x18mm xience sierra stent delivery system (sds) was advanced but failed to reach the lesion and the tip of the sds became deformed and damaged, possibly stretched.Additionally, the unspecified guidewire may have separated and may have been left in the anatomy.The sds was removed from the patient, without reported issue.There was no adverse patient effect and no clinically significant delay reported related to the use of the xience sierra stent.The procedure was completed with another xience sierra stent.Return device analysis found fluid leaking from a noted kink in the distal tip.There was a tear in the tip where the fluid was observed.No additional information has been provided.

Event Description

Subsequent to initial report and upon further review the account reported that there was difficulty crossing the lesion due to the anatomy.The guidewire used in the procedure may have broke and the xience sierra stent became may have become damaged while most likely attempting to treat a bifurcation or stenting in or near a previously implanted stent.No additional information has been provided.

Manufacturer Narrative

A visual, functional, and dimensional inspection was performed on the returned device.The reported stretched tip was confirmed.The reported product quality problem and material deformation were not confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.Additionally fluid was noted leaking from the noted kink in the distal tip.There was a tear in the tip where the fluid was observed.Although the reported product quality problem and material deformation could not be confirmed during return analysis testing, it is possible the account was referring to the observed tip damage.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 did not indicate a lot specific quality issue.There was no damage noted to the sds during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely the device interacted with the moderately calcified, moderately tortuous, severely stenosed lesion during advancement, resulting in the reported failure to advance.Further interaction with accessory devices during advancement may have contributed to the reported stretched tip and noted deformation due to compressive stress (kinked tip), as it was reported the guide wire broke, ultimately causing the noted torn tip, thus causing the leak; however, this cannot be confirmed.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported product quality problem, stretched tip and material deformation.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
• 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: 15734471
• MDR Text Key: 303340403
• Report Number: 2024168-2022-11249
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500350-18
• Device Lot Number: 1042841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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