MAUDE Adverse Event Report: CORDIS DE MEXICO UNKNOWN CYPHER JAPAN; CORONARY DRUG-ELUTING STENT

Model Number CJSXXXX

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Morofuji, t., inaba, s., aisu, h., takahashi, k., saito, m., higashi, h.,.Sumimoto, t.(2017).Heterogeneous intravascular ultrasound findings of stent thrombosis. internal medicine, 56(3), 259-268.Doi:10.2169/internalmedicine.56.7093.This article was found during a recent clinical evaluation review/literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.  the devices are cypher stents but the catalog and lot numbers are not available.  as noted in the publication by morofuji et al heterogeneous intravascular ultrasound findings of stent thrombosis, intern med (2016) 56 (3): 259-268; (b)(6) year-old man was implanted with a 2.5×13-mm self-expanding stent (ses) in the proximal left anterior descending (lad) for effort angina pectoris.After 47.5 months, the patient was admitted to our hospital because of sudden chest pain.Emergency coronary angiography revealed total occlusion at the ses-implanted site.After thrombus aspiration, intravascular ultrasound (ivus) was performed and it revealed stent under expansion (minimum stent area [msa] =3.8 mm2).We confirmed that msa at the index procedure was 4.0 mm, indicating chronic stent under expansion, not stent recoil.The product was not returned for analysis.No lot number was provided therefore a device history record (dhr) review could not be generated.The reported ¿stent under expanded¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number, catalogue code or other product information was supplied a dhr could not be completed.According to the instructions for use ¿subsequent stent blockage may require repeat dilatation of the arterial segment containing the stent.The long-term outcome following repeat dilatation of endothelialized stents is not well characterized.Coronary artery stenting is contraindicated for use in: patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.Adverse events (in alphabetical order) which may be associated with the implantation of a coronary stent in coronary arteries: incomplete stent apposition, occlusion, restenosis of stented segment (greater than 50% obstruction), stent compression, thrombosis (acute, subacute, or late).¿ the information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As noted in the publication by morofuji et al heterogeneous intravascular ultrasound findings of stent thrombosis, intern med (2016) 56 (3): 259-268; (b)(6) old man was implanted with a 2.5×13-mm self-expanding stent (ses) in the proximal left anterior descending (lad) for effort angina pectoris.After 47.5 months, the patient was admitted to our hospital because of sudden chest pain.Emergency coronary angiography revealed total occlusion at the ses-implanted site.After thrombus aspiration, intravascular ultrasound (ivus) was performed and it revealed stent under expansion (minimum stent area [msa] =3.8 mm2).We confirmed that msa at the index procedure was 4.0 mm, indicating chronic stent under expansion, not stent recoil.

• Brand Name: UNKNOWN CYPHER JAPAN
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6409371
• MDR Text Key: 70095190
• Report Number: 9616099-2017-00975
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CJSXXXX
• Device Catalogue Number: CJSXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/17/2017
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 87