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

Catalog Number 1070250-48

Device Problems Stretched (1601); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2019

Event Type  malfunction  

Manufacturer Narrative

A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that based on the angio films provided, there is not enough evidence to confirm the event.However, it may be reasonable to suggest that the patient¿s coronary anatomy and calcified vessel could have been contributing factors relating to a probable cause of the reported stent malformation.The device was returned for analysis.The reported material deformation was confirmed.There was stretching and bunching sporadically on the inner member and outer member distal to the mid lap seal.All noted device damage is likely due to handling and/or manipulation of the device during the procedure.The reported failure to advance 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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified and chronic totally occluded lesion causing the reported failure to advance and subsequent material deformation.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 heavily calcified and chronic totally occluded lesion in the right coronary artery.Following pre-dilatation, a 2.5x48mm xience xpedition stent delivery system (sds) was advanced and resistance was felt.A partial malformation to the stent was noted and the sds was withdrawn.The procedure was successfully completed with an unspecified device.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that there was stretching and bunching sporadically on the inner member and outer member (shaft) 1.5mm distal to the mid lap seal for a length of 5.5mm.No additional information was provided.

• 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
• 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: 9666676
• MDR Text Key: 177658558
• Report Number: 2024168-2020-01175
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Catalogue Number: 1070250-48
• Device Lot Number: 9011841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2019
• 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 Age: 55 YR
• Patient Weight: 80