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

Model Number 1550350-38

Device Problems No Apparent Adverse Event (3189); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is estimated.The additional xience sierra device referenced is filed under a separate medwatch report number.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.

Event Description

It was reported that the 3.5x38mm and 2.50x38mm xience sierra stents delivery system failed to deploy.Both devices were removed, and another unspecified stent was used to successfully complete the procedure.There was no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.General handling damage was noted during return analysis consistent with operational context; however, as no specific reported device malfunction was reported nothing was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.An investigation was not conducted because there were no specific reported device malfunctions or patient effects associated with the device.There is no indication of a product quality issue with respect to design, manufacture or labeling.H6: device code 3270 removed.

Event Description

Subsequent to the initially filed report, the following information was received: the devices were not deployed as it was noted that the incorrect size stents were chosen and they were undersized for the lesion.The stents were not implanted and there was no issue noted with the stents or delivery systems.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 10495262
• MDR Text Key: 207040742
• Report Number: 2024168-2020-07403
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 0033141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1