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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN PALMAZ STENT; LAPAROSCOPY KIT
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CORDIS CORPORATION UNKNOWN PALMAZ STENT; LAPAROSCOPY KIT Back to Search Results
Model Number PXXXXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative
This article was found during a recent clinical evaluation review/literature search of this device.The report also represents notification of six events for required stent redamation via balloon angioplasty because of symptom reemergence.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are palmaz stents, but the catalog and lot numbers are not available.The citation is as follows (inferior vena cava reconstruction in symptomatic patients using palmaz stents: a retrospective single-center experience).A copy of the publication is attached to this report.The product remains implanted and is thus not available for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported in the literature article by barrette, l.-x., mclaughlin, s.W., vance, a.Z., trerotola, s.O., soulen, m.C., sudheendra, d., ¿ clark, t.W.(2020).Inferior vena cava reconstruction in symptomatic patients using palmaz stents: a retrospective single-center experience.Annals of vascular surgery.Doi: 10.1016/j.Avsg.2020.01.104, six patients required stent redilation via balloon angioplasty because of symptom reemergence.From 2002 to 2019, 37 patients (mean age: 51 year) underwent ivc reconstruction with 68 palmaz stents.Indications were symptomatic chronic venous obstruction in the infrarenal and intrahepatic ivc.The device will not be returned for analysis as it is implanted.
 
Manufacturer Narrative
As reported in the literature article by barrette, l.-x., mclaughlin, s.W., vance, a.Z., trerotola, s.O., soulen, m.C., sudheendra, d., ¿ clark, t.W.(2020).Inferior vena cava reconstruction in symptomatic patients using palmaz stents: a retrospective single-center experience.Annals of vascular surgery.Doi: 10.1016/j.Avsg.2020.01.104, six patients required stent redilation via balloon angioplasty because of symptom reemergence.From (b)(6) to (b)(6) , (b)(4) patients (mean age: 51 year) underwent ivc reconstruction with (b)(4) palmaz stents.Indications were symptomatic chronic venous obstruction in the infrarenal and intrahepatic ivc.The device will not be returned for analysis as it is implanted.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed, and no determination of possible contributing factors could be made.Stent obstruction is the most common long-term complication of self-expanding stents.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore, no corrective action will be taken.
 
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Brand Name
UNKNOWN PALMAZ STENT
Type of Device
LAPAROSCOPY KIT
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
MDR Report Key9959405
MDR Text Key190696111
Report Number9616099-2020-03644
Device Sequence Number1
Product Code FDE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPXXXXX
Device Catalogue NumberPXXXXX
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/17/2020
Initial Date FDA Received04/14/2020
Supplement Dates Manufacturer Received04/27/2020
Supplement Dates FDA Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HEPARINUKN SHEATH
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