MAUDE Adverse Event Report: CORDIS CORPORATION PALMAZ GENESIS ON AMIIA; ENDOVASCULAR SDS/STENTS (FGE)

Catalog Number PG1560PMW

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

As reported, during a percutaneous transluminal angioplasty (pta) after pre-dilation and a guidewire exchange, the physician advanced/approached the intended target lesion twice with a 142 cm.Sds rx palmaz genesis mounted on an amiia 6.0 x 15 stent delivery system (sds).The sds was removed from the patient and the distal tip was noted to be frayed.Another stent was used to complete the procedure successfully.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The target lesion was the right common femoral artery to superficial femoral artery.The lesion was reported to be: a 99% stenosis, heavily calcified and mildly tortuous.Additional information has been requested.

Manufacturer Narrative

Concomitant products: cruise, st.Jude medical guidewire; chevalier universal,fmd guidewire.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

During a percutaneous transluminal angioplasty (pta) after pre-dilation and a guidewire exchange, the physician advanced/approached the intended target lesion twice with a 142 cm.Sds rx palmaz genesis mounted on an amiia 6.0 x 15 stent delivery system (sds).The sds was removed from the patient and the distal tip was noted to be frayed.Another stent was used to complete the procedure successfully.There was no reported patient injury.The target lesion was the right common femoral artery to superficial femoral artery.The lesion was reported to be a 99% stenosis, heavily calcified and mildly tortuous.Multiple attempts to obtain additional information were unsuccessful.The product was returned for analysis.A non-sterile unit of sds rx genesis amiia 6.0x15 142cm was returned.Per visual analysis the stent was in the correct position.No damages were observed.Per functional analysis a 0.014¿ guide wire (lab sample) was inserted to the tip of the wire lumen.When the wire was advanced through the wire lumen dried blood residues came out from the transition seal.The internal diameter of guide wire lumen was measured using a lab sample 0.014¿ and it was found to be within specification.The outer diameter of the proximal balloon seal was measured and it was found within specification.Per microscopic analysis the distal tip was observed to be frayed and split; no damages were observed on the marker bands, stent and balloon.The lot number was not provided; therefore a device history record (dhr) review could not be performed.The event reported by the customer as ¿stent delivery system (sds)- tracking difficulty¿ was not confirmed as functional and dimensional analysis was performed successfully.The event reported by the customer as ¿distal tip/ frayed/split/torn-in patient (peripheral)¿ was confirmed through analysis of the returned device as the distal tip was observed to be frayed and split.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (heavy calcification, mild tortuosity and a rate of stenosis of 99%) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.Neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: PALMAZ GENESIS ON AMIIA
• Type of Device: ENDOVASCULAR SDS/STENTS (FGE)
• 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: 4936252
• MDR Text Key: 6039697
• Report Number: 9616099-2015-00314
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PG1560PMW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/23/2015
• 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