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

Patient Problem Insufficient Information (4580)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is retained by the facility.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the heavily calcified, moderately tortuous, 100% stenosed right coronary artery.The patient presented with myocardial infarction and occlusion in the right coronary artery.The 3.0x48 mm xience xpedition stent was implanted and after implant, it was found that the balloon of the stent delivery system (sds) would not completely deflate.There was resistance during removal, force was used and upon further manipulation, the balloon detached from the delivery system.The patient was sent to coronary artery bypass graft (cabg) surgery and the balloon was removed.No additional information was provided.

Event Description

Subsequent to the initially filed report the following information was provided: the procedure was to treat the mid right coronary artery (rca) with moderate calcification, no tortuosity and 100% stenosis with thrombotic occlusion.The stent balloon was inflated once to 16 atmospheres (atm) and negative pressure was held for 60-70 seconds to deflate the balloon.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 investigation was unable to determine a conclusive cause for the reported deflation problem; however, factors that may contribute to deflation problems include, but are not limited to, contamination in the inflation lumen, patient anatomical morphology, patient disease state, deflation technique, contrast dilution, and inadequate connection to the deflation device.It is likely the partially deflated balloon interacted with the difficult anatomy and/or procedural device accessories during removal causing the reported difficulty to remove.The xience xpedition instructions for use (ifu) lists the steps of re-inflation of the balloon to nominal pressure and re-performing the removal procedure section for withdrawal when resistance is felt during removal of the stent delivery system.It should be noted, the device was not re-inflated per the instructions listed in the ifu.Instead, force was applied after resistance was noted during removal resulting in the reported material separation and subsequent surgical intervention, removal of a foreign body and hospitalization.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 clarifier was updated from "excessive force" to "failure to follow steps/instructions".

• 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
• MDR Report Key: 11874229
• MDR Text Key: 252317848
• Report Number: 2024168-2021-04365
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9082241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 80