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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID
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CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID Back to Search Results
Catalog Number PC0830XCE
Device Problems Detachment Of Device Component (1104); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with this lot 17528025 presented no issues during the manufacturing process that can be related to the reported complaint.
 
Event Description
As reported, when using this precise pro rx 8 x 30 stent, advanced the stent to the release position of patient to prepare for release.However by the radiography showed that the stent had fractured in the release system, so it not be released, and then withdrawn it from the patient (not released).There was no patient injury reported and the device will be returned for analysis.Additional information has been requested.
 
Event Description
As reported, when using this precise pro rx 8 x 30 stent, advanced the stent to the release position of patient to prepare for release.However by the radiography showed that the stent had fractured in the release system, so it not be released, and then withdrawn it from the patient (not released).There was no patient injury reported and the device will be returned for analysis.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored at the lab before it is distributed to the cath lab one month.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted during use on patient.The device was not in more than one piece.The procedure was completed successfully.Additional information was received per failure analysis lab the precise pro rx 8 x 30 stent was found to have the outer sheath separated.
 
Manufacturer Narrative
As reported during an interventional procedure, when advancing a precise pro rx 8 x 30 stent to the lesion, prior to the release of the stent it was noted by radiography that the stent had fractured in the delivery system.The stent was not released and the system was withdrawn from the patient.There is no patient injury reported and the device will be returned for analysis.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored at the lab before it is distributed to the cath lab one month.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted during use on patient.The device was not in more than one piece.The procedure was completed successfully.One non-sterile units of precise pro rx 8x30 was received coiled inside a plastic bag.The hemostasis valve was received opened.Per visual analysis the stent was not deployed and the precise outer body was found separated at 22.0cm from brite tip.The stent was retrieved from the precise delivery system, then it was thoroughly inspected and no fractures or damages were observed.No other damages were found on the received unit.Sem analysis was performed to the outer member separated condition with the following results: results showed that the proximal outer member (polyamide) separated areas do not present evidence of grilamid material transfer.No other issues were noted during the sem analysis.A review of the manufacturing documentation associated with lot 17528025 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The complaint reported by the customer as ¿stent ¿ fractured¿ was not confirmed since no fractures or damages were found on the stent of the received device.Upon analysis of the returned unit, an outer body separation was found on the delivery system of the received unit.The case file was updated to include this finding.The cause of the separation found on the received precise outer member could not be conclusively determined during the analysis.According to the instructions for use ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ a risk assessment has been initiated to address this issue.
 
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Brand Name
PRECISE PRO RX 8X30
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
MDR Report Key7322166
MDR Text Key101989021
Report Number9616099-2018-01972
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue NumberPC0830XCE
Device Lot Number17528025
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIPITOR1DAY, ASPIRIN1DAY,POLYVIR 11DAY SHWE 1 DAY
Patient Outcome(s) Life Threatening;
Patient Age59 YR
Patient Weight76
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