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

Catalog Number 1011710-33

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

H6: medical device problem code 2017 - incorrect prep.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 patient presented with chest pain and the procedure was to treat a lesion in the left anterior descending (lad) artery diagonal bifurcation with 90% stenosis, mild calcification and heavy tortuosity.Pre-dilatation was performed with a 3.0mm balloon.After deployment of a stent in the diagonal, the 3.5x33mm xience prime stent was positioned in the lad without preparation meaning the device was not prepared (air aspirated) prior to use.Upon attempting to prepare the lad stent, blood back flow [leak] was found in the preparation hub and was removed.Attempts were made to cross several balloons thru the stent placed in the diagonal; however, even a 1.5mm could not cross it.Then a 1.25mm balloon crossed somehow and was able to serially crush [dilate] the diagonal stent with 1.25mm, 1.5mm, 2.0mm, 2.75mm and 3.0mm balloons.The mini crush technique was then turned into double kissing (dk) crush technique which was done with another stent as it was a calcified tortuous artery, and finally the procedure was completed with a good end result.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 evaluation.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 was unable to determine a conclusive cause for the reported leak/splash.It was reported that the stent delivery system was not prepared (air aspirated) prior to use.It should be noted the xience prime / xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent system (eecss), instructions for use (ifu) specifies: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.Do not bend the product hypotube when connecting to the inflation device/syringe.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the ifu deviation directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9/h3 - device available for evaluation updated from ¿yes¿ to ¿no¿.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported leak/splash was confirmed.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 was unable to determine a conclusive cause for the reported leak/splash.There is no indication of a product quality issue with respect to manufacture, design, or labeling.It was reported that the stent delivery system was not prepared (air aspirated) prior to use.It should be noted the xience prime / xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent system (eecss), instructions for use specifies: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.Do not bend the product hypotube when connecting to the inflation device/syringe.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the ifu deviation directly caused or contributed to the reported event.D9/h3: subsequent to filing the initial reports, the device was returned.Device return status updated from no to yes.H6: component code 4755 removed and 525 added.Type of investigation code 4115 removed and 10 added.

• Brand Name: XIENCE PRIME LL 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: 17633251
• MDR Text Key: 322088174
• Report Number: 2024168-2023-09365
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011710-33
• Device Lot Number: 2121641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/03/2023; 01/02/2024
• Supplement Dates FDA Received: 10/20/2023; 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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 Age: 42 YR