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

Catalog Number UNK RX XPEDITION

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The udi number is not known as the part and lot number were not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.It was reported that negative pressure was held for 3 to 5 seconds prior to retraction.It should be noted the xience xpedition 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 possible that the ifu deviation contributed to the reported deflation problem.It was reported that the contrast mixture used during the procedure was 1:2 with saline.It should be noted that the xience xpedition instructions for use states: use 60% contrast diluted 1:1 with normal saline.In this case, it is possible that the ifu deviation contributed to the reported deflation problem.It was reported that the device was prepared (air aspiration) inside the anatomy.It should be noted that the xience xpedition ifu states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.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.It is unknown if the ifu deviations directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, factors that could contribute to a deflation problem include, but are not limited to, deflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen, and/or damage to the inflation lumen.In this case, it was noted that the balloon was not allowed sufficient time to deflate before an attempt was made to remove the device, in addition, a contrast mixture of 1:2 with saline was used, possibly resulting in the reported deflation problem; however, this cannot be confirmed.Per the xience xpedition ifu, it 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.The ifu also specifies: use a 60% contrast diluted 1:1 with normal saline.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat the left anterior descending (lad) artery without calcification and without tortuosity.There was no difficulty removing the stylet or protective sheath of a xience xpedition stent delivery system (sds); however, the device was not prepared (air aspiration) outside the anatomy prior to use.The contrast mix was 1:2 saline.The balloon was inflated twice with 10-12 atmospheres (atms) and the stent was implanted in the lad, however, the pressure pump pumped negative pressure and the balloon was difficult to deflate.The balloon was held negative for 3-5 seconds to deflate the balloon.The balloon was inflated to post-dilate the stent per standard practice and the balloon was successfully deflated.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 14170488
• MDR Text Key: 289906634
• Report Number: 2024168-2022-04316
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XPEDITION
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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