MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE OTW 2.5 X 28MM; XIENCE ALPINE BALLOON STENT DEVICE

Catalog Number 1145250-28

Device Problems Unknown (for use when the device problem is not known) (2204); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2015

Event Type  malfunction  

Event Description

Delay in reporting due to just aware of event with all details.A (b)(6) male to hospital for mi and requiring intervention.Had an angiogram with stent placement.During the procedure the cardiologist was going to advance a xience stent into the right coronary artery.The stent stopped in the mid segment and was unable to advance it beyond that point due to the presence of heavy calcification and tortuosity.The stent catheter was removed to find that the stent was no longer on the catheter.Md looked and found the stent located in the proximal segment of the rca and it is not deployed.Md worked and was able to get stent over this stent to secure stent from migration.Good blood flow following this stent placement.It is reported that the balloon stent device of this product was reported and turned over to the sales representative of the company back in (b)(6) so they could report this event to the fda.The pt discharged home a few days later.

• Brand Name: XIENCE ALPINE OTW 2.5 X 28MM
• Type of Device: XIENCE ALPINE BALLOON STENT DEVICE
• Manufacturer (Section D): ABBOTT VASCULAR; 3299 lakeside drive; santa clara CA 95054 2807
• MDR Report Key: 5385327
• MDR Text Key: 37042869
• Report Number: 5385327
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1145250-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2016
• Distributor Facility Aware Date: 11/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR