MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; STENT, CORONARY

Model Number 26270

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that the stent failed to expand, requiring additional intervention.The 75% stenosed target lesion was located in the moderately calcified upper left arm and directly above v side anastomosis.A 6.00mm/2.0cm/50cm peripheral cutting balloon was used together with two wallstent (8x47x75 and 7x34x75).The wallstents were implanted on (b)(6) 2020.During the procedure, the first wallstent that was placed in the middle part of the upper arm during the previous treatment, was expanded to 6 atm for four times with a slight shift from the central part to the periphery each time.Indentation was not obtained as confirmed by contrast imaging, thus additional expansion was performed at 10 atm for three times, similarly while shifting.After that, without removing from the sheath, the second wallstent that was previously placed was on the elbow and v side anastomosis, and was expanded at 6 locations at 10 atm in the same way.Also, the central side and the peripheral side within the stent are expanded once at 10 atm.When imaging was taken of the whole arm for the purpose of final confirmation, incomplete dilation/expansion was observed in both the middle part of the upper arm and the elbow, so additional dilation/expansion was performed two times at 10 atm in each of the upper arm stent and the elbow stent; expansion was 19 times in total.Upon removal, resistance was felt when the balloon approached the sheath.When the device was removed, it was then noted that the proximal side of one blade got lifted and curled to the outside.The procedure was completed after confirming that the other blades were attached to the balloon as per usual and that there were no abnormalities in the fluoroscopy and contrast imaging of the entire arm.Both wallstent were implanted inside patient's body.There were no patient complications reported.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Type of Device: STENT, CORONARY
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10277689
• MDR Text Key: 198930547
• Report Number: 2134265-2020-09381
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729320067
• UDI-Public: 08714729320067
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P940019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0022915427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE - RADIFOCUS 0.018; INFLATION DEVICE - EVEREST; INTRODUCER SHEATH - MEDIKIT 6FR 3CM
• Patient Outcome(s): Required Intervention