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

Model Number	26270
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that the stent did not full 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
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10277704
• Report Number: 2134265-2020-09382
• Device Sequence Number: 2485086
• Product Code: NIO
• UDI-Device Identifier: 08714729345671
• UDI-Public: 08714729345671
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2020
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0021965905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention