MAUDE Adverse Event Report: ABBOTT USA ABBOTT BVS GTI; CORONARY, DRUG-ELUTING STENT

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/02/2017

Event Type  Injury  

Event Description

On (b)(6) i was implanted with an abbott bvs stent in lad by dr.(b)(6) costing me (b)(6).At the time i was advised by the hospital that bvs has better results than the conventional stent.Later on (b)(6) i am facing problems with the stent.The doctor thinks that it might not be absorbing fully.I can't afford more tests or treatment.What should i do? abbott is not bothered or listening to me.What do i do, please help me.I am facing problems with this stent since it is giving me pressure.What will happen if it is not absorbing?.

• Brand Name: ABBOTT BVS GTI
• Type of Device: CORONARY, DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT USA
• MDR Report Key: 6968467
• MDR Text Key: 90110462
• Report Number: MW5072886
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 69