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

Catalog Number 1500300-38

Device Problem Stretched (1601)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the circumflex (cx) artery with moderate calcification and not highly tortuous.The 3.0x38mm xience sierra stent was implanted, however, appeared to have elongated to 43mm when viewed via optical coherence tomography (oct).The extra 5mm is believed to be in healthy tissue.There was no movement or migration from its location.There was no adverse patient effect and there was 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.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that in the image provided, the views at the top show what appears to be stent struts.The physician has adjusted the measurement of the stent to account for the struts in the image.The actual measurement of the stent cannot be determined by the image provided.The whole pull-back would be required for evaluation.It is probable that one of a couple of things may have complicated this measurement.The calibration of the oct catheter may be inaccurate or incorrect.If the physician is sure that the calibration was appropriate, there is another factor that may have come into play.It is non-uniform rotational distortion which may account for the inaccuracy of the image.In the image provided, the top left image shows stent struts but they are distorted in that some look like normal struts and some appear to be larger than expected.This indicates that the image may be inaccurate.The entire pullback would be needed for the assessment.It is difficult to tell from the one still image.The xience sierra stent is likely not elongated and the issue is the probable cause of the confusion.Additionally, the oct catheter is not indicated for the proximal vessel and the measurement is greater than 5 mm.This is additional but not a high contributor to the reported complaint.In summary, it is possible that the cause of the issue is the oct system and not the stent system.The full pullback would be required to confirm the cause.Additionally, a software review was performed regarding the oct software, the reviewer concluded that there is no evidence of a software issue.There is always a possibility of small fluctuations in measured length due to cardiac motion during the oct pullback.In this case, it seems as though the timing of the pullback aligned with a portion of the heart cycle in which the heart was moving the most and the fastest relative to the catheter.In this case, based on the clinical review and software review the reported difficulties appear to be related to operational circumstances as the imaging system appears to be the cause of the inaccurate stent length measurement.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed report, additional information was received that the oct system was the optisi next ultreon f.0.1 build 2 sn: 19397905.Software review states, "there is no evidence of software issue.There is always a possibility of small fluctuations in measured length due to cardiac motion during the oct pullback.In this case, it seems as though the timing of the pullback aligned with a portion of the heart cycle in which the heart was moving the most and the fastest relative to the catheter." no additional information was provided.

• 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: 16988639
• MDR Text Key: 315798638
• Report Number: 2024168-2023-05502
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500300-38
• Device Lot Number: 2102841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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 Sex: Male
• Patient Ethnicity: Hispanic