MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939293074030

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.A 7x40x130 innova stent was selected for a bilateral iliac artery intervention.During introduction into the right iliac artery, the stent pre-deployed in the patient.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The device returned may be the incorrect device sent back.The customer summary states that the stent was pre-deployed in the body.The additional information also states that questions were asked related to the wrong device being sent back; however, the sales representative could not confirm the discrepancy.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The device was returned with the thumbwheel lock intact and the pull rack was at the start position.The outer sheath was kinked at the nosecone.A kink was noticed on the mid-shaft located at 4.3cm from the proximal markerband.The stent was returned outside of the device and showed no use, or fluids on the stent to show that it was inside the body.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.A 7x40x130 innova stent was selected for a bilateral iliac artery intervention.During introduction into the right iliac artery, the stent pre-deployed in the patient.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7627485
• MDR Text Key: 112004792
• Report Number: 2134265-2018-05470
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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 Expiration Date: 08/31/2018
• Device Model Number: H74939293074030
• Device Catalogue Number: 39293-07403
• Device Lot Number: 18339047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• 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