MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE TAXUS® LIBERTÉ® ATOM¿; CORONARY DRUG-ELUTING STENT

Model Number H7493893620220

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device is combination product.If implanted, give date: 2010.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr 2134265-2015-06555.It was reported that following stent implantation, continuous pain occurred.In 2010, a 10 x 2.25mm taxus liberte stent and a 16 x 2.25 mm taxus liberte stent were implanted.After the stents were implanted the patient experienced quite a bit of pain.The patient was hospitalized two more times after thinking she had suffered more heart attacks but the hospitals told her she was fine and had not had additional heart attacks.She was admitted and treated with unknown medications.The patient intends to follow up with their cardiologist.

• Brand Name: TAXUS® LIBERTÉ® ATOM¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5116954
• MDR Text Key: 27217644
• Report Number: 2134265-2015-06556
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Patient
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2011
• Device Model Number: H7493893620220
• Device Catalogue Number: 38936-2022
• Device Lot Number: 13031749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization