MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070275-48

Device Problems Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.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 a lesion in the left anterior descending (lad) coronary artery.Pre-dilatation was performed with a 2.0x15 mm mini trek balloon dilatation catheter (bdc).Optical coherence tomography (oct) was performed and showed fibrotic and low calcium in the target vessel.The 2.75x48 mm xience xpedition stent was deployed; however, the balloon inflated slowly at nominal pressure and did not expand the stent adequately.Pressure was increased to 18 and then 20 atmospheres, at which point the balloon ruptured.The device was removed without issue and post-dilatation was performed with a 3.0x15 mm nc trek bdc at nominal pressure to successfully expand the stent.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: device code 2017 - above rated burst pressure (rbp).The device was not returned for analysis.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the limited images included in this reported event does not provide enough evidence to support a reasonable evaluation as to why the stent did not fully expand at nominal pressure.However, it is noted in the incident report that the stent balloon was inflated above the rate of burst pressure, which is a probable cause for the balloon bursting.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 difficulties; however, the subsequent treatment(s) appear to be related to circumstances of the procedure.Factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.In addition, factors that may contribute to inflation issues include, but are not limited to, patient anatomical morphology, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Furthermore, difficulty deploying the stent (difficult or delayed activation) may be attributed to several factors including, but are not limited to, stent placement, patient anatomical morphology (calcification, tortuosity), inflation technique during use of the product or undersizing of the vessel.There was no damage noted to the stent delivery system during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible there was a loose connection with the indeflator causing the reported slow inflation problem and difficulty deploying the stent (difficult or delayed activation).Over inflation of the balloon to 20 atmospheres (atm) in an attempt to fully expand the stent may have possibly contributed to the reported material rupture.It should be noted that the xience xpedition 48 instructions for use (ifu) specifies the maximum rbp for a 2.75x48 mm is 18 atmospheres and states not to exceed the labeled rbp.It is possible that the ifu deviation contributed to the reported material rupture.Based on the information provided and without the product to examine, a definitive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

• 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: 9860877
• MDR Text Key: 187405173
• Report Number: 2024168-2020-02714
• 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: 06/29/2020

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 Expiration Date: 05/27/2022
• Device Catalogue Number: 1070275-48
• Device Lot Number: 9052141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: BMW UNIVERSAL II
• Patient Outcome(s): Required Intervention