MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN CYPHER OUS; CORONARY DRUG-ELUTING STENT

Catalog Number CYPHEROUS

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) received a notice from (b)(6) hospital regarding a patient claim.They were informed by the hospital that the patient received operation and implanted with three cypher stents in 2012.Two of stents (product codes and lots are unknown) were found broken in 2017.The patient had to receive heart bypass surgery as the result of the broken stent.The patient claimed the defects of the cypher stents caused the damage to his body.The products were not returned for analysis.(b)(4) - the product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿stent fractured - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics may have contributed to the reported event.According to a review article ¿stents are more likely to fracture in the presence of the following factors: balloon or stent overexpansion, as it may theoretically weaken the stent struts; stent overlap, which results in localized rigidity creating hinge points that deform the stent leading to fracture; stent length: longer stents may be subjected to higher radial forces; inappropriate handling of stent; stenting technique: an example of stenting technique that might cause stent fracture is crush technique.A case has been reported of stent strut fracture in a bifurcation lesion treated with crush stenting, resulting in restenosis.Anatomic and pathologic factors which include the following: tortuous and highly angulated vessel; long lesions; change in vessel angulation after stent implantation, which can create a significant distortion force; complex lesions, as it was more frequent in the complex lesion subset of chronic total occlusion; stent location, as it is more common in right coronary artery (rca) and saphenous graft locations as these vessels are dynamic during cardiac contractions.Stents in these locations may be subjected to repetitive distorting forces, as some segments of these vessels have more flexion points during the cardiac cycle.Repetitive cardiac contraction exposes the stent to compression, torsion, kinking, elongation, bending, and shear stress, which can cause fracture from mechanical fatigue.The points of stent fractures are usually located at hinges subjected to either medial or shear forces created by non-uniform vessel anatomy.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

(b)(4) received a notice from (b)(6) hospital regarding a patient claim.They were informed by the hospital that the patient received operation and implanted with three cypher stents in 2012.Two of stents (product codes and lots are unknown)were found broken in 2017.The patient had to receive heart bypass surgery as the result of the broken stent.The patient claimed the defects of the cypher stents caused the damage to his body.

• Brand Name: UNKNOWN CYPHER OUS
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7519096
• MDR Text Key: 108426009
• Report Number: 1016427-2018-01455
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CYPHEROUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• 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): Life Threatening; Required Intervention