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

Model Number 26920

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the stent foreshortened which required a second stent to be placed.A 6x80x75 innova was selected for a patient procedure to recanalize the 100% occluded superficial femoral artery.The lesion had a normal amount of tortuosity and was 5% calcified.The length of the lesion was measured to be around 6-7 cm long.The innova was selected and the inner pouch confirmed that the label showed 6x80x75.The stent was then deployed without any issues.Post deployment, the implantable length was measured to be 60 cm.Due to the stent shortening, a second stent was deployed to cover the intended length of the lesion.The patient's condition following procedure was fine.A week after the procedure, occlusion occurred on the proximal portion of the vessel; right above the area where the stents were implanted.The patient's latest reported condition was okay.No further complications were reported.

Event Description

It was reported that the stent foreshortened which required a second stent to be placed.A 6x80x75 innova was selected for a patient procedure to recanalize the 100% occluded superficial femoral artery.The lesion had a normal amount of tortuosity and was 5% calcified.The issues.Post deployment, the implantable length was measured to be 60 cm.Due to the stent shortening, a second stent was deployed to cover the intended length of the lesion.The patient's condition following procedure was fine.A week after the procedure, occlusion occurred on the proximal portion of the vessel; right above the area where the stents were implanted.The patient's latest reported condition was okay.No further complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.Correction: patient codes: changed from 2199 to 2688.Device evaluated by mfr: 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.The customer provided photos.In the second photo a measurement of 57.71mm was taken which appears to be for the implanted stent.Visual examination revealed a kink at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and implanted so it did not return for product analysis.There is blood present on and in the device.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8600233
• MDR Text Key: 144718594
• Report Number: 2134265-2019-04869
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0023332762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention