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 Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

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

Event Date 09/09/2021

Event Type  malfunction  

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 that the procedure was performed to treat a lesion in the mildly calcified, moderately tortuous, 80% stenosed proximal left anterior descending coronary artery.After pre-dilatation with unspecified 1.2x8mm and 2x8mm balloons, a 3x48mm xience xpedition stent delivery system (sds) was advanced.During deployment, it was noted that there was no stent present on the device.Per hospital staff, they did not notice whether the stent was present on the sds prior to advancement in patient anatomy.A same sized xience xpedition stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly calcified, moderately tortuous, 80% stenosed proximal left anterior descending coronary artery.After pre-dilatation with unspecified 1.2x8mm and 2x8mm balloons, a 3x48mm xience xpedition stent delivery system (sds) was advanced.During deployment, it was noted that there was no stent present on the device.Per hospital staff, they did not notice whether the stent was present on the sds prior to advancement in patient anatomy.A same sized xience xpedition stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account confirmed the xience xpedition was prepped prior to sheath/stylet removal.No additional information was provided.

Manufacturer Narrative

Device code 2017 - incorrect prep a visual inspection was performed on the returned device.The reported missing component 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.It was reported that the xience xpedition was prepped prior to sheath/stylet removal.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss) instructions for use specifies to remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent (at the proximal balloon bond site), and with the other hand, grasp the stent protector and gently remove distally.Ifu states: flush the guide wire lumen with hepns using the flushing tool supplied with the product.In addition, it was reported that the stent implant was not on the balloon after the device had been advanced into the anatomy.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss) instructions for use states: prior to using the xience xpedition 48 everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.The investigation was unable to determine a conclusive cause for the reported missing components.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 12605419
• MDR Text Key: 277199848
• Report Number: 2024168-2021-09052
• 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
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-48
• Device Lot Number: 1041341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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