MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26921

Device Problems Mechanical Problem (1384); Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that premature deployment occurred.The stenosed target lesion was located in the superficial femoral artery.A 5 x 120 x 130 innova was selected for an arterial implantation procedure of the lower limb.During the procedure, great resistance was felt.The device was removed from the patient and flushed again.The stent was found to be deployed 2mm and could not be recovered.The safety lock was not opened.The procedure was completed with another of the same device.There were no patient complications and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent is partially deployed 6mm from the tip.Microscopic examination revealed no additional damages.The thumbwheel lock is not on correctly.The rack and sheath are no longer in the manufactured location.Inspection of the remainder of the device, revealed no other damage or irregularities.Device analysis showed the lock is not on correctly while the sheath and rack are no longer in the manufactured position which would contribute to the partial deployment.It is likely that procedural factors contributed to the creation of the kink which led to the difficulty to cross the lesion.

Event Description

It was reported that premature deployment occurred.The stenosed target lesion was located in the superficial femoral artery.A 5 x 120 x 130 innova was selected for an arterial implantation procedure of the lower limb.During the procedure, great resistance was felt.The device was removed from the patient and flushed again.The stent was found to be deployed 2mm and could not be recovered.The safety lock was not opened.The procedure was completed with another of the same device.There were no patient complications and the patient's status was stable.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15056546
• MDR Text Key: 296223212
• Report Number: 2124215-2022-25218
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0028019466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 78 KG