MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070250-28

Device Problems Positioning Failure (1158); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.However, factors that could contribute to failure to deploy and inflation issues include, but are not limited to, inadequate balloon pressure, lumen obstruction due to kink or bend, and poor or incorrect connection to accessories (inflator, syringe) during inflation.The investigation determined the reported failure to deploy and inflation issue appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the non-tortuous, non-calcified, 90% stenosed, mid left anterior descending (lad) coronary artery.A 2.50 x 28 mm xience xpedition stent delivery system (sds) was advanced to the lesion, but the balloon could not be inflated; therefore, the stent implant could not be deployed.A new 2.50 x 28 mm xience xpedition sds was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the stent delivery system interacted with guiding catheter or patient anatomy (90% stenosed) during advancement to the lesion causing the noted stretched outer member including the reported wrinkled balloon and subsequent inflation issue and failure to deploy.The investigation determined the reported failure to deploy and inflation issue appears to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing noncomformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar incidents.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7139685
• MDR Text Key: 95977994
• Report Number: 2024168-2017-10061
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Catalogue Number: 1070250-28
• Device Lot Number: 7051541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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