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

Catalog Number 1070350-23

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Failure to Advance (2524); Defective Device (2588); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat severe in-stent restenosis in the coronary arteries.The restenosis was predilated with drug eluting balloons.The 3.5x23 mm xience xpedition stent delivery system was inserted, but it was unable to cross the vessel and became stuck in the anatomy resulting in damage to the stent struts.It is unclear if an attempt was made to deploy the stent.Another xience xpedition of the same size was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Event Description

Subsequent to the previously filed report, additional information was received: during the attempt to cross the ostium of the left anterior descending coronary artery, the distal stent struts became flared from the attempt to cross the lesion.The physician believes the xience xpedition stent met resistance with the uncalcified anatomy due to a defect of the stent.The stent delivery system was not inflated for stent deployment.There was no additional information provided.

Manufacturer Narrative

(b)(4).Device status changed from returning to not returned; (b)(4) were removed.The device was not returned for analysis.A device operating differently than expected can be affected by numerous factors including, but not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, product placement technique, product size selection and accessory product support.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Review of the complaint history identified no similar incidents from this lot.Although a conclusive cause for the reported device operating differently than expected cannot be determined, the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the stenosed anatomy causing the reported failure to advance and subsequent material deformation (stent flare).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 7373789
• MDR Text Key: 103684773
• Report Number: 2024168-2018-02210
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2019
• Device Catalogue Number: 1070350-23
• Device Lot Number: 6011841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70