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

Catalog Number 1128350-33

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Device Embedded In Tissue or Plaque (3165)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported the procedure was performed to treat the mid right coronary artery with mild calcification.A xience 3.50 x 33 drug eluding stent (des) was inserted and deployed.It was noted the balloon was inflated to 16atm.After deployment of the stent, it was observed the balloon would not deflate.It was then observed the patient went into junctional bradycardia with long pauses.The physician attempted to pull the balloon out, but the balloon tore at the level of the balloon markers, resulting in a clinically significant delay in the procedure.Atropine was administered to treat the bradycardia.A snare was inserted in an attempt to remove the balloon but was unsuccessful.A wire was then inserted and was able to slowly deflate the fractured balloon.A stent was then inserted and was able to trap the fractured balloon to coronary wall.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was performed to treat the mid right coronary artery with mild calcification.A xience 3.50 x 33 drug eluding stent (des) was inserted and deployed.It was noted the balloon was inflated to 16atm.After deployment of the stent, it was observed the balloon would not deflate.It was then observed the patient went into junctional bradycardia with long pauses.The physician attempted to pull the balloon out, but the balloon tore at the level of the balloon markers, resulting in a clinically significant delay in the procedure.Atropine was administered to treat the bradycardia.A snare was inserted in an attempt to remove the balloon but was unsuccessful.A wire was then inserted and was able to slowly deflate the fractured balloon.A stent was then inserted and was able to trap the fractured balloon to coronary wall.Subsequent to the initially filed report, the following information was received: the physician only pulled negative pressure for 5 to 10 seconds.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code 2017/failure to follow steps a visual and functional inspection was performed on the partially returned device.The reported material separation was confirmed.The reported entrapment of the device could not be tested as it was based on operational circumstances.The reported deflation problem could not be tested due to the condition of the returned device.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 other incidents.It was reported that negative pressure was held for 5 to 10 seconds prior to retracting into the guide catheter.It should be noted the xience pro a/alpine everolimus eluting coronary stent systems instructions for use (ifu) specifies: deflate the balloon by pulling negative on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer.In this case, it is likely the ifu deviation contributed to the reported event.A medical review was performed by an abbott vascular medical reviewer who provided the following summary: this was a case to treat in-stent restenosis (isr) in a right coronary artery (rca).The xience proa des was reportedly deployed at 16 atm for 16 seconds, well within the recommended inflation range of 10 atm to 18 atm, but for half the recommended inflation time of 30 seconds.Per the xience proa des ifu1: after the successful deployment of the xience proa des, the stent balloon would not deflate.This xience proa des was a 3.5mm x 33cmm, a larger/longer balloon, and the negative pressure should have been held for at least 30 seconds.It was reported that negative pressure was held for 5 to 10 seconds before retracting into the guide catheter.Reportedly force was used during the removal attempts of the inflated stent balloon, which caused the stent delivery catheter to stretch and separate at the level of the balloon markers, leaving the balloon segment within the patient¿s coronary artery.Multiple attempts to retrieve the separated segment with a snare were unsuccessful.A chronic total occlusion (cto) wire was used to puncture the inflated balloon; this successfully caused the balloon to deflate slowly.An additional unknown stent was deployed in the coronary artery to embed the separated balloon portion into the vessel wall.It is unknown if an attempt was made to re-inflate the balloon to the nominal pressure of 10 atm, per the ifu1, before attempting to forcefully remove the inflated balloon from the coronary artery, causing the stent delivery catheter to separate.In this case, it is likely the balloon was not allowed sufficient time to deflate before an attempt was made to remove the device from the anatomy, contributing to the reported deflation problem and causing the reported entrapment of the device.Further manipulation of the stent balloon catheter during retraction likely contributed to the noted inner/outer member stretching, ultimately causing the reported separation.Failure to follow the xience proa des instructions for use regarding proper inflation time and deflation time, proper post-stent deployment removal of the stent balloon, or the precautions statements1 ultimately caused the stent delivery catheter to fracture and separate.The investigation determined the reported deflation problem, entrapment of the device and material separation appear to be related to the use error, as it is likely the balloon was not allowed sufficient time to deflate before an attempt was made to remove the device from the anatomy, contributing to the reported deflation problem, causing the reported entrapment of the device.Further manipulation of the sds during retraction likely contributed to the noted inner/outer member stretching, ultimately causing the reported material separation (inner member) and noted outer member material separation.It was reported that negative pressure was held for 5 to 10 seconds prior to retracting into the guide catheter.The xience pro a/alpine instructions for use specifies to deflate the balloon by pulling negative on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer.A snare was inserted in an attempt to remove the balloon but was unsuccessful.A wire was then inserted and was able to slowly deflate the fractured balloon.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments including device embedded in tissue or plaque, medication required and delay to treatment/therapy appear to be related to the operational context of the procedure.There was no damage noted to the device prior to use during preparation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE PROA 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14789592
• MDR Text Key: 294603083
• Report Number: 2024168-2022-06761
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1128350-33
• Device Lot Number: 1102561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• 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