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

Catalog Number 1070300-18

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.(b)(4).The device is expected to be returned for investigation.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 percutaneous coronary interventional procedure was to treat a 70% stenosed lesion in the left circumflex artery.A 3.00x18mm xience xpedition stent delivery system (sds) was not able to cross due to calcification and interaction with the guide wire and guiding catheter, despite pre-dilation and the use of the guide extension.Multiple attempts to cross the sds were made by re-inserting the sds.The shaft separated into two pieces during removal.The procedure was successfully completed with another 3.00x18mm xience xpedition stent.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported failure to advance could not be replicated in testing environment as it was related to operational context of the procedure.The reported difficulty to advance (guide wire) could not be confirmed.The reported difficulty to advance (guiding catheter) and difficulty to remove could not be confirmed due to the condition the device was 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.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.In this case, it does not appear the ifu deviation related to re-insertion contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the calcification and device accessories causing the reported difficulty/failure to advance.The device was re-inserted during multiple attempts to cross the lesion; however, the device was unable to successfully cross the lesion.The device met resistance once again with the difficult anatomy and/or device accessories causing the reported difficulty to remove and subsequent material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the cines partially confirmed the no-cross event of the initial 3.0x18 mm xpedition.The shaft separation was not visible via the cine films so was also not able to be confirmed.No device malfunction was observed with the cine films provided.

Event Description

The following additional information was received: there was resistance during removal of the xience xpedition stent delivery system.The separated shaft was simply withdrawn.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
• MDR Report Key: 9450902
• MDR Text Key: 177935938
• Report Number: 2024168-2019-14383
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Catalogue Number: 1070300-18
• Device Lot Number: 9030241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDELINER; GUIDING CATHETER XB 3.5 .
• Patient Age: 68 YR
• Patient Weight: 80