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

Catalog Number 1070275-33

Device Problems Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)

Patient Problems Angina (1710); Foreign Body In Patient (2687)

Event Date 03/14/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 85% stenosed lesion in the left anterior descending (lad) artery.A 2.75x33mm xience xpedition drug eluting stent (des) was implanted at the target lesion; however, the delivery system balloon failed to deflate after negative was held for 5 minutes.Attempts were made to deflate the balloon, but the balloon failed to deflate.The patient experienced chest tightness.The shaft was pulled, causing the distal portion of the delivery system to become separated from the device.The proximal delivery system and the guide wire (gw) were simply removed from the patient; however, the separated portion with the inflated balloon, remained pinned under the stent in the target lesion.The patient was transferred to vascular surgery.Coronary artery bypass surgery was performed.The separated balloon was not removed and remains within the stented lesion.The patient remained hospitalized.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

H6: medical device problem code 2017 - incorrect device preparation, incorrect contrast mix the device was returned for analysis.The reported material separation was confirmed.The reported failure to deflate could not be confirmed due to the condition the device was returned for analysis.The reported entrapment could not be replicated in a testing environment as it was related to operational context of the procedure.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.The reported patient effects of angina is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.It was reported xience xpedition stent delivery system (sds) was prepped with 100% contrast and was not prepped prior to insertion into the anatomy.It should be noted that the xience xpedition everolimus eluting coronary stent system ifu lists 60% contrast diluted 1:1 with normal saline for device preparation.Additionally, the ifu states: prepare an inflation device/syringe with diluted contrast medium.Stent preparation should be performed prior to insertion into the anatomy.In this case, it appears the instruction for use (ifu) deviation related to incorrect contrast dilution may have contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to the reported ifu deviation of prepping with 100% contrast which likely caused the reported failure to deflate.Contrast is a highly viscous liquid with temperature sensitive that, as the fluid cools, can increase the viscosity.The combination of 100% contrast vs.A 1:1 mix as well as the potential for temperature increasing the viscosity could lead to delayed / poor deflation time.The delayed deflation likely resulted in the reported entrapment of the device and subsequent shaft separation.The patient reportedly experienced angina due to the separated portion remaining in the lesion.A coronary artery bypass surgery was performed; however, the separated balloon was not removed and remains within the stent lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, the following information was received: pure contrast was used to perform the procedure.It was not mixed with saline.

• 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: 13912035
• MDR Text Key: 288310007
• Report Number: 2024168-2022-03189
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070275-33
• Device Lot Number: 1093041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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; Hospitalization; Disability