MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20212

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Thrombosis/Thrombus (4440)

Event Date 03/14/2022

Event Type  Injury  

Event Description

It was reported that removal difficulty, vessel occlusion and vasospasm occurred.Vascular access was obtained via left radial approach.The 99% stenosed target lesion was located in the severely tortuous and severely calcified subclavian artery.After a 5fr non-boston scientific sheath was placed and a non-boston scientific guidewire crossed the lesion, pre-dilatation was performed with a 5mmx20mm sterling balloon catheter.A 8.0x30x135cm express ld vascular stent was advanced for treatment.However, it was noted that the device could not be inserted from the hub part of the sheath and was stuck in the mid lesion.Subsequently, the device was brought in to the lesion by pushing and pulling and was finally implanted at nominal pressure.When the delivery system balloon was removed, a spasm in the degree of radial pulse was observed and the patient did not feel any blood flow after the procedure.A day after the procedure, the patient stated that he had no subjective symptoms such as numbness.In addition, there were symptoms that could be diagnosed as mild cerebral infarction immediately after surgery, such as when the express ld was brought in or implanted in the subclavian artery without a backup sheath.The physician reported that a thrombus possibly embolized into the vascular artery at some unknown time, causing an adverse event that could be diagnosed as cerebral infarction.There were no further patient complications reported after the surgery; however, the patient will be monitored for the next two weeks.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that removal difficulty, vessel occlusion and vasospasm occurred.Vascular access was obtained via left radial approach.The 99% stenosed target lesion was located in the severely tortuous and severely calcified subclavian artery.After a 5fr non-boston scientific sheath was placed and a non-boston scientific guidewire crossed the lesion, pre-dilatation was performed with a 5mmx20mm sterling balloon catheter.A 8.0x30x135cm express ld vascular stent was advanced for treatment.However, it was noted that the device could not be inserted from the hub part of the sheath and was stuck in the mid lesion.Subsequently, the device was brought in to the lesion by pushing and pulling and was finally implanted at nominal pressure.When the delivery system balloon was removed, a spasm in the degree of radial pulse was observed and the patient did not feel any blood flow after the procedure.A day after the procedure, the patient stated that he had no subjective symptoms such as numbness.In addition, there were symptoms that could be diagnosed as mild cerebral infarction immediately after surgery, such as when the express ld was brought in or implanted in the subclavian artery without a backup sheath.The physician reported that a thrombus possibly embolized into the vascular artery at some unknown time, causing an adverse event that could be diagnosed as cerebral infarction.There were no further patient complications reported after the surgery; however, the patient will be monitored for the next two weeks.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: an express ld device was returned for analysis.A visual examination of the shaft identified inner balloon shaft damage.The recommended introducer sheath size for this express ld device is a 6fr (2.00mm).The investigator was unable to insert the device through a 6fr sheath as there was inner balloon shaft damage, and the investigator did not want to damage the device further.The guide used by the customer was not returned for analysis.A visual examination of the returned device confirmed that the balloon was bunched on the distal end.The device was returned with the stent deployed from the delivery system.The deployed stent was not returned for analysis.No issues were noted with the tip of the device.

• Brand Name: EXPRESS LD VASCULAR
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14059331
• MDR Text Key: 288988645
• Report Number: 2134265-2022-03496
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0028238813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Outcome(s): Other