MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070300-48

Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562); Failure to Deflate (4060)

Patient Problem Pain (1994)

Event Date 03/31/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately calcified, mildly tortuous lesion in the right coronary artery (rca).Radial access was gained in the arm and the 3.00x48mm xience xpedition drug eluting stent (des) was advanced to the lesion and implanted without issue, however the balloon ruptured on the first inflation to 12 atmospheres (atm).Upon attempted removal of the delivery system from the anatomy, negative was held from 3 to 5 seconds, however the balloon was unable to be deflated.Multiple attempts were made to try to deflate the balloon; however, this was unsuccessful.The balloon was taken to the access point in the arm and was attempted to be pulled out, but the patient experienced discomfort and the balloon separated from the delivery system.A snare device was used and was able to retrieve the separated balloon.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for analysis.The returned delivery system had the outer member separated at mid-lap seal and inner member separated about 1 cm distal to the exit notch.The reported failure to deflate could not be confirmed due to the condition the device was received for analysis.The reported entrapment could not be replicated in a testing environment as it was related to operational context of the procedure.The reported material separation of the balloon could not be confirmed as the distal portion of the separated outer member and inner member, including the balloon, stent and tip, were not returned.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 from this lot.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported entrapment and material separation appear to be related to operational context of the procedure.It should be noted, there was no damage noted to the device during the inspection prior to use or device preparation which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There was no damage noted to the device during the inspection prior to use or device preparation which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.Additionally, an abbott vascular clinical specialist reviewed the provided cine images and reported difficulties and indicated the following: the complaint summary indicated that the delivery catheter balloon was deflated for 3-5 seconds.This is a short time for deflation of a 38 mm balloon catheter.There were several attempts to rupture the balloon which may indicate further attempts to deflate the balloon.If the delivery system catheter was retracted with force prior to fully deflating, the inner member of the delivery system may stretch and prevent deflation of the balloon catheter.The delivery system did separate upon the attempt to retract through the radial insertion site so it is unclear if the inner member was stretched prior to reaching the insertion site.It is unable to be determined if this scenario contributed to the lack of deflation from the videos provided.A second cine was received and reviewed by an abbott vascular clinical specialist.This video shows the delivery system balloon in a partially inflated state with a wire alongside the balloon.There is a defect in the mid-portion of the delivery system balloon where it appears that the balloon has ruptured but the has maintained contrast within the balloon catheter.This is likely because the rupture is not large enough to allow for the complete escape of contrast.The defect is able to be identified within the image below.The video shows an angled balloon which indicates a probable kink in the catheter along with the retained contrast in the delivery system balloon.The complaint summary indicated that the delivery catheter balloon was deflated for 3-5 seconds.This is a short time for deflation of a 38 mm balloon catheter.There were several attempts to rupture the balloon which may indicate further attempts to deflate the balloon.If the delivery system catheter was retracted with force prior to fully deflating, the inner member of the delivery system may stretch and prevent deflation of the balloon catheter.The delivery system did separate upon the attempt to retract through the radial insertion site so it is unclear if the inner member was stretched prior to reaching the insertion site.It is unable to be determined if this scenario contributed to the lack of deflation from the videos provided.Medical device problem code 1546 removed.

• Brand Name: XIENCE XPEDITION 48 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: 16808653
• MDR Text Key: 313938849
• Report Number: 2024168-2023-04291
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-48
• Device Lot Number: 2090141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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 Outcome(s): Required Intervention