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

Model Number 26921

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.An innova 6 x 150 x 130 stent was selected for use in the interventional recanalization procedure to treat an arterial occlusion in the lower extremity.The target lesion was located in the superficial femoral artery (sfa).When the innova delivery system was advanced to the sfa and deployment was attempted, the stent only deployed halfway before becoming stuck.The innova was unable to release fully.The entire system was removed.The procedure was completed using a different device and the patient was reported to be stable.

Manufacturer Narrative

Device analysis: 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 and a kink to the inner liner, 16.2cm from the tip.The nosecone was damaged, and a portion was broken off and missing.The nosecone portion of the handle was separated.Microscopic examination revealed no additional damages.The stent appeared to have been deployed and was not returned for analysis.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinked inner liner was attributable to handling after the procedure.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

Event Description

It was reported that the stent partially deployed.An innova 6 x 150 x 130 stent was selected for use in the interventional recanalization procedure to treat an arterial occlusion in the lower extremity.The target lesion was located in the superficial femoral artery (sfa).When the innova delivery system was advanced to the sfa and deployment was attempted, the stent only deployed halfway before becoming stuck.The innova was unable to release fully.The entire system was removed.The procedure was completed using a different device and the patient was reported to be 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: 16991460
• MDR Text Key: 315830731
• Report Number: 2124215-2023-24880
• 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: 06/22/2023

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: 0029036514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 55 KG