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

Catalog Number CXS33275

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985)

Event Date 07/10/2013

Event Type  Injury  

Event Description

As reported by the (b)(4) study, the patient had a moderate non-q-wave myocardial infarction (mi) approximately 39 months post implantation of three non-study cypher stents in the right coronary artery (rca).Elevated cardiac enzymes were noted.The event was medically managed and resolved without sequelae; catheterization with no intervention.The event did not require revascularization.As the grafts were patent, no further intervention is required.The event was deemed unrelated to the index procedure, cypher stent, and study drug.There was recurrent ischemic symptoms lasting 10 minutes or more.There was no recurrent ischemic pain x 20 minutes, unrelieved by ntg.There was no st elevation, depression, or bundle branch block (bbb).There was no evidence of stent thrombosis.There was 100% restenosis in the distal rca 2.75 x 33mm cypher stent.The patient had 100% ostial left anterior descending (lad) artery restenosis.The restenosis in the ostial lad was within 5mm of the cypher stent implanted in the proximal lad at the time of the index procedure.The patient is currently in stable condition.Two days prior to the study index procedure, the patient had been admitted with a stemi mi due to total occlusion of the rca, which was treated with the three cypher rx stents (2.75 x 33mm, 3.50 x 33mm, & 3.00 x 23mm).At the time of the index procedure, the patient had a 2.50x28mm cypher stent implanted in the proximal lad.The target lesion was de-novo, length 20mm, and had a rate of 90% stenosis.There were no complications and the patient was discharged three days later.Approximately two weeks later, the patient had a planned staged procedure and had three cypher stents implanted in the proximal to distal circumflex.There were no complications and the patient was discharged 2 days later.The stents in the circumflex are patent at this time.

Manufacturer Narrative

This adverse event had previously been reported under manufacturing report number 3003742446-2014-00013.This supplemental report contains additional information.The adverse events related to this patient have been previously reported under associated manufacturer report numbers 3003742446-2011-00334, 3003742446-2014-00013, 3003742446-2014-00014 & 3003742446-2014-00015 through a different complaint handling system.The newly associated manufacturer report numbers are as follows: 3003742446-2014-00073, 3003742446-2014-00074, 3003742446-2014-00075, & 3003742446-2014-00076.Adjudication minutes were received and reviewed.The cec disagreed with the event of mi (protocol definition), but there was not enough information to support removal of this determination.Additional details were received from the clinical events committee (cec) meeting minutes that the patient presented to the emergency department with severe chest pain and tightness that radiated to the left arm and was associated with shortness of breath.Chest pain severity was 7/10.After arrival to the emergency department he received asa and ntg which reduced the pain to 3/10.He denied diaphoresis, palpitation, cough, or abdominal pain.Lab values were provided.The ecg core lab reported new persistent intraventricular conduction delay, no new major st-t abnormalities, and no new q waves.Due to elevated cardiac enzymes the patient was started on thienopyridine medication and enoxaparin.Repeat angiography the day after admission on (b)(6) 2013 revealed a severe three-vessel disease with patent grafts to lad and cx, angiographically normal lmca, a discrete 100% ostial lesion in the lad, angiographically normal cx, a 100% distal lesion in the rca with collateral flow from lad to the right pda and collateral flow from the cx to the right pav.Lvef was 25%.Medical therapy was recommended.The patient was discharged two days following admission.This information does not change the conclusion of the complaint.

• 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: 4371274
• MDR Text Key: 5116895
• Report Number: 3003742446-2014-00075
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: CXS33275
• Device Lot Number: 15097311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREVIOUSLY REPORTED.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 93