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 Problems Aneurysm (1708); Inflammation (1932)

Event Date 03/01/2015

Event Type  Injury  

Event Description

As reported in the publication by kurosawa et al a case of active peri-stent inflammation after sirolimus-eluting stent implantation; heart vessels 30 (2015) 270¿273; an 83-year-old japanese woman with a history of hypertension, chronic atrial fibrillation and ischemic stroke had a history of aortocoronary bypass surgery 12 years prior to her death due to critical limb ischemia related to sepsis.She had undergone pci with ses implantation in the left circumflex coronary artery (lcx) for cardiac ischemia 3 years prior to her death.Final ivus showed no stenotic lesion, but incomplete expansion of the ses.Since the patient was receiving three anti-thrombotic drugs (aspirin 162 mg, clopidogrel 75 mg and warfarin 1.5 mg), there were no ischemic events since the last pci.Postmortem pathological investigation demonstrated no acute ischemic changes in the myocardium, although there was intense lymphocytic and eosinophilic infiltration in the coronary artery around the area of the ses (2.5 x 18 mm), especially in the adventitia.However, systemic blood examination did not reflect them throughout the process.The maximum counts of each corpus were 968 l/l in lymphocyte, 32 l/l in eosinophil and 752 l/l in monocyte (all did not exceed normal range).Disruptions of the elastic membrane (open arrows) opposite the site of the calcified plaque (asterisk) were also observed.There was thinning of the medial layer consisting of smooth muscle cells, due to vascular injury following stent deployment.The crescentic space in the mid-lcx corresponded to the area of the reconstruction, which was created by high-pressure dilatation with a 2.75 x 10 mm non-compliant balloon inflated to a pressure of 22 atmospheres.

Manufacturer Narrative

Concomitant products: aspirin 162 mg, clopidogrel 75 mg, and warfarin 1.5 mg, 2.75 x 10 mm non-compliant balloon.The device will not be returned for analysis.Additional information will be submitted within 30 days of receipt.Please note the attached literature article for the complaint.

Manufacturer Narrative

Upon further review, it was noted that based on the size of the product, the catalogue code would be cjs18250.(b)(4).

Manufacturer Narrative

Literature citation: kurosawa et al.2015.A case of active peri-stent inflammation after sirolimus-eluting stent implantation.Heart vessels, 30, 270-273.

Manufacturer Narrative

Literature citation: kurosawa et al.2015.A case of active peri-stent inflammation after sirolimus-eluting stent implantation.Heart vessels, 30, 270-273.Complaint conclusion: as reported through a published article, a cypher stent was noted to be incompletely expanded.The patient is reported to have expired three years later related to sepsis as a result of critical limb ischemia.The event involved a (b)(6) female patient with a past medical history of hypertension, chronic atrial fibrillation, ischemic stroke and coronary artery bypass grafting.She presented with symptoms of cardiac ischemia, was noted to have a target lesion in her circumflex artery and underwent 2.5 x 15mm cypher stent implantation.Final intravascular ultrasound (ivus) revealed no residual stenosis but an incompletely expanded stent.This appears to have been further treated with post dilation with a non-compliant balloon at 22 atmospheres.Post-procedurally, the patient received anticoagulant and antiplatelet medications with no further evidence of ischemic events.Approximately three years after the index procedure, the patient expired from sepsis related to her critical limb ischemia.A postmortem pathological investigation revealed no acute ischemic changes to the myocardium; although the exam did reveal intense lymphocytic and eosinophilic infiltration in the coronary artery around the area of the previously implanted cypher stent.This was especially evident in the adventitia.There was thinning of the medial layer consisting of smooth muscle cells, due to vascular injury following the stent deployment.The crescentic space in the mid circumflex corresponded to the area of the reconstruction, which was created by high-pressure dilatation with a 2.75 x 10 mm non-compliant balloon inflated to a pressure of 22 atmospheres.The product was not returned for evaluation.A review of the manufacturing records could not be conducted without a lot number.According to the product instructions for use, users are instructed at several points in the document that the optimal stent expansion requires the stent to be in full contact with the artery wall, with the stent internal diameter matching the size of the reference vessel diameter.Stent wall contact should be verified through routine angiography or ivus.They are further instructed to confirm adequate stent expansion by angiographic injection through the guide catheter.All efforts should be taken to assure that the stent is not under-dilated.If the deployed stent size is still inadequate or if full contact with the vessel is not achieved, the stent may be further expanded using a low profile, high pressure, and non-compliant balloon catheter.The user is cautioned to not dilate the stent beyond 3.5mm (for a stent with a nominal stent diameter of 2.25-3.00mm.Based on the available information, it is not possible to determine what factors may have contributed to the reported issue; though the article does appear to implicate the post-dilation of the stent in the post-mortem findings.Without the return of the device for analysis, the reported event could not be confirmed and no determination of possible contributing factors could be made.Without a lot number to conduct a manufacturing review, it is not possible to determine if the reported event could be related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

The device was not returned for analysis, and no sterile lot number was provided, therefore no product analysis nor dhr review was performed.

• 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: 4730303
• MDR Text Key: 5735963
• Report Number: 9616099-2015-00192
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CJSXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• 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): Life Threatening
• Patient Age: 83 YR