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 Break (1069); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

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.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 chronic totally occluded, mildly tortuous, and heavily calcified de novo lesion in the right coronary artery.The patient presented with an inferior myocardial infarction.A 2.5x48mm xience xpedition stent delivery system (sds) failed to cross due to resistance with the anatomy.The stent fractured and the distal end was distorted.The procedure was successfully completed with a new unspecified xience xpedition stent.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 inspection was performed on the returned device.The reported stent fracture/break and material deformation was not confirmed.The reported failure to advance could not be tested 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.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure; however, the investigation was unable to determine a conclusive cause for the reported stent fracture/break and material deformation.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: 10673498
• MDR Text Key: 211257447
• Report Number: 2024168-2020-08560
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Catalogue Number: 1070250-48
• Device Lot Number: 8021241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 95