MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070250-48

Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.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 moderately tortuous and heavily calcified lesion in the mid left anterior descending artery.The 2.5x48 mm xience xpedition stent delivery system (sds) met resistance with the calcified anatomy during advancement and the shaft separated about 20 cm distal from the hub.Additionally, resistance with the anatomy was felt when removing the sds.The separation was outside the guiding catheter; therefore no intervention was required to remove the separated portion.The procedure was successfully completed with three non-abbott stents.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspections were performed on the returned sds.The reported shaft separation was confirmed.The reported failure to advance and difficulty to remove were unable to be replicated in a testing environment as it was based on operational circumstances.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 did not indicate a lot specific quality issue.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appears to be related to operational circumstances of the procedure.Based on the reported information, during advancement and retraction the sds encountered resistance with the moderately tortuous and heavily calcified anatomy.It likely that manipulation against resistance caused the hypotube to kink resulting in the hypotube separation.The hypotube fractured faces at the separation were ovalled as if kinked prior to separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10284165
• MDR Text Key: 199535395
• Report Number: 2024168-2020-05892
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Catalogue Number: 1070250-48
• Device Lot Number: 9101841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1