MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed and difficult to reconstrained.The patient underwent iliac vein stenting and left femoral vein puncture.The physician advanced the guidewire and sheath, then the physician performed high pressure imaging through the sheath.After the lesion position was confirmed, the physician advanced the guidewire to the proper position in inferior vena cava.The physician used a 6x100 mustang and 12x60 xxl balloon catheters were used for pre-dilatation.The physician confirmed common iliac ostial and decided to implant a 14x90/9fr 75cm wallstent endoprosthesis.The stent was deployed inside the patient, but under dsa, the physician could see the stent got stuck in the half way of deployment, and it could not continue to deploy.The physician constrained the stent and re-deployed the stent.But when it came to the same position, the stent could not deploy as well as could not reconstrained.So the physician retrieved the device by simply pulling it out from the patient.After retrieving the stent out of the patient, it was found the stent delivery outer sheath was kinked.The stent could not be used.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Event or Problem Description
It was reported that the stent was partially deployed and difficult to reconstrained.The patient underwent iliac vein stenting and left femoral vein puncture.The physician advanced the guidewire and sheath, then the physician performed high pressure imaging through the sheath.After the lesion position was confirmed, the physician advanced the guidewire to the proper position in inferior vena cava.The physician used a 6x100 mustang and 12x60 xxl balloon catheters were used for pre-dilatation.The physician confirmed common iliac ostial and decided to implant a 14x90/9fr 75cm wallstent endoprosthesis.The stent was deployed inside the patient, but under dsa, the physician could see the stent got stuck in the half way of deployment, and it could not continue to deploy.The physician constrained the stent and re-deployed the stent.But when it came to the same position, the stent could not deploy as well as could not reconstrained.So the physician retrieved the device by simply pulling it out from the patient.After retrieving the stent out of the patient, it was found the stent delivery outer sheath was kinked.The stent could not be used.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: received a wallstent uni back for analysis, the device was received with the stent partially deployed.The stent was also noted to be damaged.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues with the shaft of the device.This concludes the product analysis.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14803191
• Report Number: 2134265-2022-06715
• Device Sequence Number: 4653515
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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 Expiration Date: 11/22/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028429300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 49 KG