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

Catalog Number 1070300-48

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.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 material deformation; however, factors that could contribute to material deformation include, but are not limited to, interaction with accessory devices, interaction with patient anatomical morphology, patient disease state and product damage during handling by user.The reported additional therapy/non-surgical treatment appears to be related to circumstances of the procedure.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.

Event Description

It was reported that the procedure was performed to treat a de novo left anterior descending lesion that was 90% stenosed.Pre-dilatation was done with an unspecified 2.5x15mm balloon at 22-26 atmospheres (atm).A 3.0x48mm xience xpedition stent was deployed at 10atm.Post dilatation was done with a 3.0x15mm non-abbott balloon at 16-24atm.Then the xience xpedition stent was noted to be stretched at the proximal end for about 5-6mm.The stretched portion was post dilated with a 4.0x15mm non-abbott balloon at 14-20atm then with a 4.5x10mm unspecified nc balloon at 20atm.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A cine was received and reviewed by an abbott vascular clinical research specialist and two cardiologists.The conclusion of the reported stent elongation is inconclusive on the basis of available evidence.Stent elongation may be associated with premature withdrawal of either the stent delivery system or a postdilatation device before full deflation has occurred, especially in circumstances where the stent is either under expanded or incompletely apposed to the vessel wall.Stent elongation is very rarely due to device malfunction/deficiency, but (as the compliant report summary says) more usually associated with interaction between the native vessel architecture, the stent and any post-stent devices passed into the coronary.The finding of stent elongation can be confirmed sometimes angiographically, but more often (to be sure), intracoronary imaging may be required to be absolutely certain.The investigation was unable to determine a conclusive cause for the reported stretched stent (stent elongation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: removed device code 2976 and replaced with 1601; removed results code 114 and replaced with 3221.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9570203
• MDR Text Key: 178347782
• Report Number: 2024168-2020-00501
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9060641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NC SAPPHIRE 3.0X15MM
• Patient Outcome(s): Required Intervention