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

Model Number H74939293061830

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Age at the time of the event: 18 years or older (b)(4).Device evaluated by mfr: returned product consisted of an innova¿ stent for damage.Visual examination showed a kink at the nosecone.The mid-shaft showed multiple areas of kinks and twists.The stent was returned in the device.With the damage on the mid-shaft which houses the stent, most likely the stent would suffer damage due to the damage on the mid-shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that stent damage occurred.An innova¿ stent was selected for a procedure in the superficial femoral artery (sfa).The target lesion was located in a severely tortuous anatomy with 100% stenosis and the lesion was severely calcified.Contralateral approach was performed in the sfa.Pre dilation was performed using a mustang balloon.After approaching the iliac from the opposite side, the sheath bounced at the approached part into the aorta when trying to deliver the innova¿.The stent was kinked and the device was retrieved at this time.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: 6670946
• MDR Text Key: 78501893
• Report Number: 2134265-2017-06236
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190831(10)19664968
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 19664968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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
• Treatment: GUIDEWIRE-35 RADIFOCUS; INTRODUCER SHEATH- PARENT 45CM