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 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The 142 cm.Palmaz genesis peripheral stent on cordis amiia.014" 6.0 x 15 stent delivery system (sds) was delivered to the lesion but its distal stent edge got frayed.It was removed from the patient and there was no reported patient injury.It is unknown how the procedure was completed.The target lesion was the renal artery and was reported to be: heavily calcified and heavily tortuous and rate of stenosis was (b)(4).The procedure was completed successfully.There is no reported information to explain how the procedure was completed or with what devices.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.The following information was reported as unknown: if there was any stent strut uplift noted; if it appeared to have moved on the delivery system; if there was any other product issue noted either at the account or after the procedure; if the device passed through any acute bends; if any difficulty was encountered while advancing/tracking the device towards the lesion; if there was any unusual force used at any time during the procedure; or if there was thrombus present prior to, at, or after the lesion site.The product was not returned for analysis.A device history record (dhr) review of lot 17277701 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip frayed/split/torn-in patient (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of heavy calcification and tortuosity and a rate of stenosis of (b)(4) may have contributed to the reported event.According to the instructions for use ¿contraindications include, but may not be limited to: patients with highly calcified lesions resistant to pta.Prior to stenting, the palmaz genesis peripheral stent on cordis amiia.014" delivery system should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Should any resistance be felt at any time during advancement or removal of the stent delivery system pre-stent implantation and before full exposure of the stent, carefully attempt to pull the unexpanded stent delivery system back through the sheath introducer/guiding catheter.If resistance is felt in doing so, the delivery system must be removed as a single unit.When removing the delivery system as a single unit: do not retract the delivery system into the sheath introducer/guiding catheter.Position the proximal balloon marker just distal to the tip of the sheath introducer/guiding catheter.Advance the guidewire into the anatomy as far distally as safely possible.Secure the stent delivery system to the sheath introducer/guiding catheter; then remove the sheath introducer/guiding catheter and stent delivery system as a single unit.Failure to follow these steps and/or applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and/or stent delivery system components such as the balloon.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.Please note that this is the initial/final report for this file.

Event Description

As reported, the palmaz genesis 6.0 x 15 stent mounted on a 142 cm.Rx amiia stent delivery system (sds) was delivered to the lesion but its distal stent edge got frayed.It was removed from the patient and there was no reported patient injury.It is unknown how the procedure was completed.The target lesion was the renal artery and was reported to be: heavily calcified and heavily tortuous and rate of stenosis was (b)(4).The product was clinically used and it will not be returned for analysis.Additional information has been received.The procedure was completed successfully.There is no reported information to explain how the procedure was completed or with what devices.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the device prior to use.The following information was reported as unknown: if there was any stent strut uplift noted; if it appeared to have moved on the delivery system; if there was any other product issue noted either at the account or after the procedure; if the device passed through any acute bends; if any difficulty was encountered while advancing/tracking the device towards the lesion; if there was any unusual force used at any time during the procedure; or if there was thrombus present prior to, at, or after the lesion site.

• 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: 5820689
• MDR Text Key: 50392936
• Report Number: 9616099-2016-00468
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/30/2016

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 Expiration Date: 05/31/2018
• Device Catalogue Number: PG1560PMW
• Device Lot Number: 17277701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1