MAUDE Adverse Event Report: ABBOTT VASCULAR STENT XIENCE ALPINE 3.00 X 15 - CV

Model Number STENT XIENCE ALPINE 3.00 X 15 - CV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 12/17/2016

Event Type  Injury  

Event Description

Drug eluting stent placed and now with intractable transfusion dependent hematuria which cannot be controlled without stopping her "required" dual antiplatelet medications.Stent xience alpine 3.00 x 15 - cv - (b)(4) - implanted.Inventory item: stent xience alpine 3.00 x 15 - cv model/cat number: 1125300-15, manufacturer: abbott vascular, lot number: 6071941.Device identifier: (b)(4).

• Brand Name: STENT XIENCE ALPINE 3.00 X 15 - CV
• Type of Device: STENT XIENCE ALPINE 3.00 X 15 - CV
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 6208685
• MDR Text Key: 63508489
• Report Number: MW5066917
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: STENT XIENCE ALPINE 3.00 X 15 - CV
• Device Catalogue Number: 1125300-15
• Device Lot Number: 6071941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 69