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

Catalog Number CJSXXXX

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Thrombosis (2100)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows.Sato, a et al (2015, july, 29).Efficacy of endeavor zotarolimus eluting stent implantation for the treatment of very late stent thrombosis with late acquired incomplete stent apposition after sirolimus eluting stent implantation.Heart vessels.The publication has been attached to the med watch.Complaint conclusion: a reported in the article ¿efficacy of endeavor zotarolimus eluting stent implantation for the treatment of very late stent thrombosis with late acquired incomplete stent apposition after sirolimus eluting stent implantation¿, one patient developed a subtotal occlusion of a previously implanted cypher stent.This occlusion was also associated with positive remodeling and late-acquired incomplete stent apposition with thrombus.The patient was treated with thrombectomy, balloon angioplasty and the placement of a non-cordis drug eluting stent with no further reported patient injury.The event involved a (b)(6) female patient who presented with chest pain and underwent successful cypher stent implantation in her left anterior descending artery.Seven years after the index procedure, the patient underwent coronary angiography that revealed a subtotal occlusion of the previously implanted cypher stent.Further diagnostic testing with intravascular ultrasound revealed positive remodeling and late-acquired incomplete stent apposition with thrombus.The patient was treated with thrombectomy and balloon angioplasty.In order to treat diffuse plaque beyond the distal edge of the cypher stent, a non-cordis drug eluting stent (des) was implanted.Follow up angiography twelve months later revealed non-cordis des patency and neointimal proliferation.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a product lot number.Without the return of the device for analysis, the reported ¿stent ¿ underexpanded¿ and ¿thrombosis in device¿ events could not be confirmed and no determination of possible contributing factors could be made.According to the instructions for use, potential adverse events associated with the implantation of this product include, but are not limited to, events such as occlusion, restenosis and thrombosis.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.Complaint conclusion: a reported in the article ¿efficacy of endeavor zotarolimus eluting stent implantation for the treatment of very late stent thrombosis with late acquired incomplete stent apposition after sirolimus eluting stent implantation¿, one patient developed a subtotal occlusion of a previously implanted cypher stent.This occlusion was also associated with positive remodeling and late-acquired incomplete stent apposition with thrombus.The patient was treated with thrombectomy, balloon angioplasty and the placement of a non-cordis drug eluting stent with no further reported patient injury.The event involved a (b)(6) female patient who presented with chest pain and underwent successful cypher stent implantation in her left anterior descending artery.Seven years after the index procedure, the patient underwent coronary angiography that revealed a subtotal occlusion of the previously implanted cypher stent.Further diagnostic testing with intravascular ultrasound revealed positive remodeling and late-acquired incomplete stent apposition with thrombus.The patient was treated with thrombectomy and balloon angioplasty.In order to treat diffuse plaque beyond the distal edge of the cypher stent, a non-cordis drug eluting stent (des) was implanted.Follow up angiography twelve months later revealed non-cordis des patency and neointimal proliferation.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a product lot number.Without the return of the device for analysis, the reported ¿stent ¿ underexpanded¿ and ¿thrombosis in device¿ events could not be confirmed and no determination of possible contributing factors could be made.According to the instructions for use, potential adverse events associated with the implantation of this product include, but are not limited to, events such as occlusion, restenosis and thrombosis.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

Event Description

As reported in a publication, efficacy of endeavor zotarolimus eluting stent implantation for the treatment of very late stent thrombosis with late acquired incomplete stent apposition after sirolimus eluting stent implantation.A (b)(6) woman presented to our hospital with chest pain.A sirolimus-eluting stent (ses) had been implanted in her left anterior descending artery 7 years earlier.Coronary angiography (cag) revealed subtotal occlusion of the ses.Intravascular ultrasound (ivus) showed positive remodeling and late-acquired incomplete stent apposition with thrombus.Following thrombus aspiration and balloon dilatation, an endeavor zotarolimus-eluting stent (zes) was implanted because diffuse plaque was present beyond the distal edge of the ses.Cag and ivus 12 months later revealed endeavor zes patency and neointimal proliferation.

• 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 ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5038378
• MDR Text Key: 24367403
• Report Number: 9616099-2015-00396
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CJSXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR