MAUDE Adverse Event Report: CORDIS CORPORATION STENT PER 39MM 4-9MM X-LARGE; STENT, CORONARY

Model Number	P394
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/1999
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This article was found during a recent clinical evaluation review/literature search of this device.The report also represents notification of 2 events for stent migration and inaccurate placement.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 " management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology: jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2".A copy of the publication is attached to this report.This is one of two products involved with the reported event.The medical device reporting reference number for the other event is 9616099-2021-04629.According to the literature article by slonim, s.M., dake, m.D., razavi, m.K., kee, s.T., samuels, s.L., rhee, j.S., & semba, c.P.(1999).Management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology : jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2, a palmaz p308 stent and a palmaz p394 stent were intended to be placed in the superior vena cava (svc) but migrated to the right common iliac vein (r civ) due to both stents being too small.The palmaz p308 stent was repositioned in the right common iliac vein (r civ) percutaneously with another unknown 3-5mm balloon catheter.The palmaz p394 was repositioned in the left external iliac vein (l eiv) percutaneously with another unknown 3-5mm balloon catheter.Because the palmaz p394 did not oppose the walls of the vein, another non cordis 24mm stent was used.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿stent migration¿ and ¿stent inaccurate placement¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number was supplied a phr could not be completed.According to the safety information in the instructions for use ¿the palmaz balloon-expandable peripheral stent is a 316l stainless steel, slotted tube.The stent should be crimped over the recommended balloon delivery catheter.See materials required table for the recommended cordis maxi¿ ds, and powerflex® plus individual product descriptions, and recommended accessory devices.¿ the recommended balloon was the maxi ds and the powerflex plus, respectively.It is not known if the recommended balloons were used in this case.The limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
According to the literature article by slonim, s.M., dake, m.D., razavi, m.K., kee, s.T., samuels, s.L., rhee, j.S., & semba, c.P.(1999).Management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology : jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2, a palmaz p308 stent and a palmaz p394 stent were intended to be placed in the superior vena cava (svc) but migrated to the right common iliac vein (r civ) due to both stents being too small.The palmaz p308 stent was repositioned in the right common iliac vein (r civ) percutaneously with another unknown 3-5mm balloon catheter.The palmaz p394 was repositioned in the left external iliac vein (l eiv) percutaneously with another unknown 3-5mm balloon catheter.Because the palmaz p394 did not oppose the walls of the vein, another non cordis 24mm stent was used.The devices will not be returned for evaluation.

• Brand Name: STENT PER 39MM 4-9MM X-LARGE
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11990258
• Report Number: 9616099-2021-04630
• Device Sequence Number: 3268943
• Product Code: MAF
• UDI-Device Identifier: 10705032076241
• UDI-Public: 10705032076241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P890017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: P394
• Device Catalogue Number: P394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANOTHER UNKNOWN 3-5MM BALLOON CATHETER; UNKNOWN 3-5MM BALLOON CATHETER; WALLSTENT 2445
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention