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

Catalog Number 1070275-48

Device Problems Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

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.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a narrow lesion located in the left anterior descending coronary artery that was both heavily calcified and tortuous and 70% stenosed.The lesion was pre-dilated with a traveler balloon.A xience xpedition 48 stent delivery system (sds) was advanced against resistance to the lesion and once deployed, it was noted that the stent struts were flared, and the shaft separated into 2 pieces.The sds was then successfully removed from the body via a snare device.Two xience sierra stents were implanted, possibly to treat the flared stent struts and an nc traveler was used for post-dilatation.There was no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported material deformation was not confirmed as there was no damage noted to the stent implant.The reported difficult to advance and failure to advance were unable to be replicated in a testing environment as they were 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 difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the narrow, heavily calcified, tortuous and 70% stenosed anatomy resulting in the reported difficult to advance and failure to advance.Manipulation of the device ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.: reported details serial number date of implant - stent was not implanted device code (b)(4) - removed.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the xience xpedition 48 stent failed to reach the lesion and was not implanted as previously reported; however, there was a proximal shaft separation that required snaring to be removed from the anatomy.Once removed from the anatomy, the struts of the stent were noted to be flared.Two xience sierra stents were implanted to treat the lesion.No additional information was provided.

• 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: 10027320
• MDR Text Key: 189982378
• Report Number: 2024168-2020-04127
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Catalogue Number: 1070275-48
• Device Lot Number: 9012941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 53