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

Catalog Number 1070250-38

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

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.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The stent material deformation was confirmed.The reported difficult to position and difficult to remove the device through an rhv was unable to be replicated due to the condition of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was being advanced, the rhv was not fully opened and an interaction between the device and rhv resulted in the reported difficulty to position resulting in the noted winkled balloon shoulder, distal shaft and the flared tip of the device.As the device was being withdrawn, interaction with the rhv resulted in the reported difficult to remove causing the reported material deformation (stretched struts).A review of the lot history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 other similar incidents reported from this lot.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the mildly tortuous, proximal left anterior descending artery.The 2.5 x 38 mm xience xpedition stent delivery system (sds) was advanced; however, became caught in the rotating hemostatic valve (rhv) prior to entering the anatomy.After retraction of the sds from the rhv, distal stent edge flaring was observed.The sds was removed from the rhv with some resistance felt.Two xience xpedition stents (3.0 x 33 mm and 3.5 x 23 mm) were able to be deployed via direct stenting successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• 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: 6977711
• MDR Text Key: 90970344
• Report Number: 2024168-2017-08472
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: 1070250-38
• Device Lot Number: 6093041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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