MAUDE Adverse Event Report: CORDIS CORPORATION CYPHER SIROLIMUS-ELUTING CORONARY STENT; DRUG-ELUTING STENT (NIQ)

Catalog Number CYPHER

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

A cypher patient called for medical information and additionally reported adverse events.On (b)(6) 2004 patient had a cypher stent implanted in an unspecified vessel for severe chest pain during a treadmill test (results not obtained) after having burning in chest and loss of breath on exertion.Patient was discharged home the next day, (b)(6) 2004.Beginning on (b)(6) 2004 patient experienced an unknown event, maybe discomfort.Patient was admitted to the hospital on (b)(6) 2004 and a cypher stent was implanted in an unspecified vessel.Patient was discharged home the next day, (b)(6) 2004.Patient reported at time of call he was in the process of gathering safety information to have the mri scheduled and performed.No additional information obtained at time of call including lot number, patient's date of birth, age at time of event, height and weight.

Manufacturer Narrative

Concomitant products: plavix (75mg/daily ) (uu/uuu/2003 - ong) ), atenolol (25mg/daily ) (uu/uuu/2003 - ong) ), aspirin (81mg/daily ) (uu/uuu/2003 - ong) ), zetia (uu/uuu/2003 - ong) ).Complaint conclusion: a cypher patient called for medical information and additionally reported adverse events.On (b)(6) 2004 patient had a cypher stent implanted in an unspecified vessel for severe chest pain during a treadmill test (results not obtained) after having burning in chest and loss of breath on exertion.Patient was discharged home the next day, (b)(6) 2004.Beginning on (b)(6) 2004 patient experienced an unknown event, maybe discomfort.Patient was admitted to the hospital on (b)(6) 2004 and a cypher stent was implanted in an unspecified vessel.Patient was discharged home the next day, (b)(6) 2004.Patient reported at time of call he was in the process of gathering safety information to have the mri scheduled and performed.No additional information obtained at time of call including lot number, patient's date of birth, age at time of event, height and weight.There was no sterile lot number provided and the device was not returned, therefore no dhr review will be performed and no product analysis will be completed.This patient is at risk for progression of coronary artery disease based on their medical history which included previous smoking.Restenosis is associated with the progression of cardiovascular disease and is a known potential adverse event following stent implantation.Restenosis is a well-documented potential complication of stent placement is subsequent intimal hyperplasia and occlusion.Progression of atherosclerosis is an expected outcome of the disease process.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process, therefore no corrective action is needed.

• Brand Name: CYPHER SIROLIMUS-ELUTING CORONARY STENT
• Type of Device: DRUG-ELUTING STENT (NIQ)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; rd 362 km 0 5; san german 00000 ; 7863133880
• MDR Report Key: 4933034
• MDR Text Key: 19814852
• Report Number: 3003742446-2015-00041
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P020026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CYPHER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention