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

Model Number 26921

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

Event Description

It was reported that part of the stent was exposed.A 6 x 60 x 130 innova self-expanding stent was selected for use.Upon unpacking, part of the stent at the tip was found exposed.The safety lock was not yet removed from the handle when the issue was noted.Then, the physician tried to deliver the stent into the patient, however, resistance was felt, and the device could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient status was stable.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).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 multiple kinks along the sheath.The stent is partially deployed 3mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock is still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that part of the stent was exposed.A 6 x 60 x 130 innova self-expanding stent was selected for use.Upon unpacking, part of the stent at the tip was found exposed.The safety lock was not yet removed from the handle when the issue was noted.Then, the physician tried to deliver the stent into the patient, however, resistance was felt, and the device could not be used.The procedure was completed with another of the same device.No complications were reported, and the patient status was stable.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18575160
• MDR Text Key: 333637476
• Report Number: 2124215-2024-03475
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0031087989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 82 KG