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

Catalog Number 1070250-38

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly tortuous, mildly calcified mid left anterior descending coronary artery.A 2.5x38mm xience xpedition stent delivery system (sds) faced resistance with an unspecified guiding catheter during advancement.The distal shaft of the sds became kinked, and the stent struts became flared.The stent was not implanted, and a non-abbott stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a hypotube separation.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was not confirmed.The reported kinked shaft was confirmed.Additionally, it was observed that the hypotube was separated.The reported difficulty to advance could not be confirmed due to the condition the device was received 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter causing the reported difficulty to advance.Continued interaction with the guiding catheter caused the reported device kink.The device reportedly kinked and subsequently separated as noted in return device analysis.The investigation was unable to determine a conclusive cause for the reported material deformation as no stent damage was identified during return device analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• 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: 9157227
• MDR Text Key: 171583612
• Report Number: 2024168-2019-12365
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Catalogue Number: 1070250-38
• Device Lot Number: 8072141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 90