MAUDE Adverse Event Report: ABBOTT VASCULAR XIERRO 2.5MM; STENT

Lot Number 1125250-38

Device Problem Partial Blockage (1065)

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

Event Date 12/04/2015

Event Type  Injury  

Event Description

Blockage in upper ground and coronary blockage.

• Brand Name: XIERRO 2.5MM
• Type of Device: STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 6446151
• MDR Text Key: 71457557
• Report Number: MW5068736
• 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: Other
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1125250-38
• Other Device ID Number: 5082841
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 5 MG TABLET; ASPIRIN 81 MG CHEWABLE TABLET; ATORVASTATIN 40 MG TABLET. ; FIORICET 50 - 300 - 40 MG CAPSULE; HYDROCODONE/ ACETAMINOEA 5-325 TABLET; LISINOPRIL 5 MG TABLET; METOPROLOL SUCCINATE 25 G 24 HOURS; NAPROXEN 500 MG TABLETS; NIRTROGLYCERIN 0.4 MG SUBLINGUAL TABLET; RX MEDS: ALPRA2 0.5 MG TABLET; TIZANIDINE 4 MG TABLET
• Patient Outcome(s): Hospitalization