MAUDE Adverse Event Report: CORDIS CORPORATION CYPHER SELECT + JAPAN 2.50 X 23MM; CORONARY DRUG-ELUTING STENT

Catalog Number CJB23250

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Aneurysm (1708); No Code Available (3191)

Event Date 08/24/2016

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: hyogo et al (2016, aug 24).Nine-year follow-up of progressive peri-stent contrast staining after cypher sirolimus-eluting stent implantation: a case report.Cardiovasc interv ther.Doi: 10.1007/s12928-016-0420-2.  due to system issues, the literature article in which this medwatch is reporting cannot be added as an attachment.However, the article can be viewed under this web address: http://rd.Springer.Com/article/10.1007%2fs12928-016-0420-2.  concomitant devices: one cjb28250 (2.5x28mm); two cjb23250 (2.5x23mm); one cjb28300 (3x28mm); and two cjb18250 (2.5x18mm).  please note that the (b)(4).This is one of four products involved with the reported patient from the literature article.This is case (b)(4) and other three complaints associated with this report are case (b)(4).

Event Description

As noted in the publication by hyogo et al nine-year follow-up of progressive peri-stent contrast staining after cypher sirolimus-eluting stent implantation: a case report, cardiovasc interv ther.(2016 aug 24); a (b)(6) male was referred to our hospital with a complaint of repetitive chest oppression at rest.He had no history of allergic diseases or vasculitis, but was taking 10 mg of nifedipine and 100 mg of cilostazol for hypertension and sinus bradycardia.Electrocardiography and echocardiography indicated myocardial ischemia in the inferior wall.Emergency cag and percutaneous coronary intervention (pci) for the right coronary artery were performed.Triple antiplatelet therapy with 100 mg of aspirin, 200 mg of ticlopidine, and 100 mg of cilostazol was initiated.Three days later, he underwent a staged pci for the left anterior descending artery.Cypher sirolimus-eluting stents (c-ses) were selected based on the assumption of a higher restenosis rate of lesions in the diagonal branch due to the small size of this vessel compared to the main left anterior descending artery and the greater length of the associated lesions.One month later, a second elective pci was performed for diffuse and bifurcation lesions in the left circumflex arteries.The lesions were complex, and thus a total of four c-ses were implanted.Four bare metal stents (bms) were also used during treatment of the patient, and none exhibited any significant structural or angiographic changes during the 9-year follow- up period.On the contrary, positive remodeling and progressive pss, which were indicative of stent fracture, were seen in the proximal stent in the diagonal branch at 1.5 years.Follow-up cag performed in postoperative year (poy) 5 detected progressive pss and a new distal stent fracture.Finally, aneurysmal changes were observed at both the proximal and distal stent fracture sites in poy 9.Pss was first seen in the c-ses implanted in the distal segment of the left circumflex artery in poy 5 and the lesion gradually enlarged until poy 9.The most marked changes occurred in the bifurcation lesions in the left circumflex artery, which were treated with four c-ses, including kissing stents (fig.2d).Both of the kissing stents fractured.Interestingly, the distances between the paired edges of the two fractured stents gradually increased over time in both of the fractured stents.On the other hand, increases in the number and severity of pss lesions, which were more prominent than the other lesions, were noted in the 5-year follow-up cag.During this series of follow-up studies, it was striking that the aneurysmal changes occurred where two stents came into contact or at stent fracture sites.Further evaluations of the left circumflex artery using two intravascular imaging devices were performed in poy 9.An intravascular ultrasound (ivus) examination revealed the extent of positive remodeling.Frequency domain optical coherence tomography (lunawave tm, terumo) provided additional details, such as the positional relationship between the stent and the arterial wall and the degree of neointimal proliferation on the stent surface, and also showed incomplete stent apposition and multiple interstrut hollows that could not be detected with cag or ivus.After the follow-up cag in poy 9, we proposed the option of a coronary artery bypass graft, rather than medical follow-up.The patient chose to receive surgical treatment and underwent the operation 3 months later.Since his discharge, he has remained free from major adverse cardiovascular events while taking aspirin and warfarin.

Manufacturer Narrative

This is one of four products involved with the reported patient from the literature article.The complaints associated are case-(b)(4)  (1016427-2016-00094); case-(b)(4) (1016427-2016-00093); case-(b)(4) (1016427-2016-00092); and case-(b)(4) (1016427-2016-00091).  complaint conclusion: as noted in the publication by hyogo et al nine-year follow-up of progressive peri-stent contrast staining after cypher sirolimus-eluting stent implantation: a case report, cardiovasc interv ther.(2016 aug 24); a (b)(6) year-old male was referred to our hospital with a complaint of repetitive chest oppression at rest.He had no history of allergic diseases or vasculitis, but was taking 10 mg of nifedipine and 100 mg of cilostazol for hypertension and sinus bradycardia.Electrocardiography and echocardiography indicated myocardial ischemia in the inferior wall.Emergency cag and percutaneous coronary intervention (pci) for the right coronary artery were performed.Triple antiplatelet therapy with 100 mg of aspirin, 200 mg of ticlopidine, and 100 mg of cilostazol was initiated.Three days later, he underwent a staged pci for the left anterior descending artery.Cypher  sirolimus-eluting stents (c-ses) were selected based on the assumption of a higher restenosis rate of lesions in the diagonal branch due to the small size of this vessel compared to the main left anterior descending artery and the greater length of the associated lesions.One month later, a second elective pci was performed for diffuse and bifurcation lesions in the left circumflex arteries.The lesions were complex, and thus a total of (b)(6) c-ses were implanted.(b)(4)bare metal stents (bms) were also used during treatment of the patient, and none exhibited any significant structural or angiographic changes during the 9-year follow- up period.On the contrary, positive remodeling and progressive pss, which were indicative of stent fracture, were seen in the proximal stent in the diagonal  branch at 1.5 years.Follow-up cag performed in postoperative year (poy) 5 detected progressive pss and a new distal stent fracture.Finally, aneurysmal changes were observed at both the proximal and distal stent fracture sites in poy 9.Pss was first seen in the c-ses implanted in the distal segment of the left circumflex artery in poy 5 and the lesion gradually enlarged until poy 9.The most marked changes occurred in the bifurcation lesions in the left circumflex artery, which were treated with four c-ses, including kissing stents (fig.2d).Both of the kissing stents fractured.Interestingly, the distances between the paired edges of the two fractured stents gradually increased over time in both of the fractured stents.On the other hand, increases in the number and severity of pss lesions, which were more prominent than the other lesions, were noted in the 5-year follow-up cag.During this series of follow-up studies, it was striking that the aneurysmal changes occurred where two stents came into contact or at stent fracture sites.Further evaluations of the left circumflex artery using two intravascular imaging devices were performed in poy 9.An intravascular ultrasound (ivus) examination revealed the extent of positive remodeling.Frequency domain optical coherence tomography (lunawave tm, terumo) provided additional details, such as the positional relationship between the stent and the arterial wall and the degree of neointimal proliferation on the stent surface, and also showed incomplete stent apposition and multiple interstrut hollows that could not be detected with cag or ivus.After the follow-up cag in poy 9, we proposed the option of a coronary artery bypass graft, rather than medical follow-up.The patient chose to receive surgical treatment and underwent the operation 3 months later.Since his discharge, he has remained free from major adverse cardiovascular events while taking aspirin and warfarin.  the products were not returned for analysis.No lot numbers were provided therefore device history record (dhr) reviews could be generated.  the reported ¿stent fracture ¿ in patient¿ and ¿stent ¿ migration¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown but noted to be complex and may have contributed to the reported event.Clinical studies have reported that the main risk factors for stent fracture are longer stent length, rca (right coronary artery) or saphenous vein graft lesion location, lesion with high motion, longer implant time and overlapping stents.According to the instructions for use ¿premorbid conditions that increase the risk of a poor initial result or the risks of emergency referral for bypass surgery (diabetes mellitus, renal failure, and severe obesity) should be reviewed.A review of the vessel location, reference vessel size, lesion length, qualitative target lesion characteristics, and the amount of myocardium in jeopardy from acute or subacute thrombosis must also be considered.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: CYPHER SELECT + JAPAN 2.50 X 23MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer Contact: cecil navajas ; 14201 nw 60 ave; miami lakes, FL 33014
• MDR Report Key: 6029919
• MDR Text Key: 57449067
• Report Number: 1016427-2016-00092
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CJB23250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 10/06/2016
• 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): Hospitalization; Life Threatening; Required Intervention