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

Catalog Number 1011710-38

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 - device code 2017 clarifier - incorrect removal.

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous right coronary artery (rca).The 3.5x38mm xience prime stent was deployed; however, the stent balloon only partially deflated.Multiple methods to deflate the balloon was attempted including; with an unspecified indeflator applying negative pressure and applying negative pressure with a syringe fixing to the stent hub, but unsuccessful.The stent delivery system was pulled with force and the distal shaft separated, remaining in the patient.The patient was immediately sent for emergency open heart surgery and the distal shaft portion was removed along with the stent from the rca.No clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the stent delivery system was pulled with force and the distal shaft separated, remaining in the patient.It should be noted that the xience prime everolimus eluting coronary stent system instruction for use (ifu) states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.Additionally, a contrast mix of a 1:3 ratio was used to prepare the device for use.It should be noted that the xience prime everolimus eluting coronary stent system ifu indicates that contrast diluted 1:1 with heparinized normal saline is to be used to prepare the inflation device/syringe.In this case, it is likely the instructions for use deviation related to incorrect contrast contributed to the reported event.The investigation determined the reported deflation problem appears to be related to an instruction for use deviation related to incorrect contrast medium used for device preparation.The device was reportedly prepared with a contrast mix of a 1:3 ratio.Contrast that is more concentrated can lead to slower deflation times as is likely in this case.The use of incorrect contrast mix can result in the contrast to be improperly diluted contributing to the reported deflation problem.After multiple attempts to fully deflate the balloon, removal was attempted; however, the partially deflated balloon caused difficulty in removing the device.Force was used resulting in the reported shaft separation.Surgery was performed to remove the foreign body (shaft) and implanted stent from the patient.The treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2687 removed.

Event Description

Subsequently, after the report was filed it was noted that the contrast mix ratio was 1 to 3.No additional information was provided.

• 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: 18841920
• MDR Text Key: 336956290
• Report Number: 2024168-2024-02765
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648123740
• UDI-Public: (01)08717648123740(17)260828(10)3090541
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011710-38
• Device Lot Number: 3090541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2023
• 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; Hospitalization