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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION PALMAZ GENESIS ON AMIIA; ENDOVASCULAR SDS/STENTS (FGE) Back to Search Results
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.
 
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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 Key5820689
MDR Text Key50392936
Report Number9616099-2016-00468
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
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 Date05/31/2018
Device Catalogue NumberPG1560PMW
Device Lot Number17277701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2016
Initial Date FDA Received07/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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