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

Model Number H74939181061030

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported that during a peripheral angioplasty and stenting treatment procedure, premature deployment occurred.The target lesion was located in the left femoral artery.During introduction over a zipwire the 6x100x130 innova¿ was advanced.However, the stent delivery catheter got stuck after the tip of the delivery system was just inside the introducer sheath and could not be advanced any further.The stent delivery system was removed and the outer catheter moved a bit backwards so that the distal end of the stent was exposed.The procedure was completed with a different device.No patient complications were reported and the patient status is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer - the innova stent delivery system (sds) was received with no original packaging or other devices.The safety-lock was securely attached to the thumb-wheel, as-received; however, it could not be determined if it was removed and replaced prior to return to bsc.The shaft was buckled at the distal edge of the handle.The stent was partially expanded, a length of 2 mm.The id of the inner shaft was measured to be within specification.The guidewire used in the procedure was not returned for analysis; therefore, a new.035" zipwire guidewire was used for functional testing.The zipwire was attempted to be advanced through the innova but met resistance.The zipwire was advanced 130cm; however, was unable to pass through the buckled shaft.In order to determine if there was any damage to the inner shaft the stent was deployed.There was no damage visible with the inner shaft.There was no evidence of any material or manufacturing deficiencies contributing to the confirmed partial deployment, tracking difficulty and damage.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 during a peripheral angioplasty and stenting treatment procedure, premature deployment occurred.The target lesion was located in the left femoral artery.During introduction over a zipwire the 6x100x130 innova was advanced.However, the stent delivery catheter got stuck after the tip of the delivery system was just inside the introducer sheath and could not be advanced any further.The stent delivery system was removed and the outer catheter moved a bit backwards so that the distal end of the stent was exposed.The procedure was completed with a different device.No patient complications were reported and the patient status is stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4320961
• MDR Text Key: 16631881
• Report Number: 2134265-2014-07643
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

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: 09/03/2017
• Device Model Number: H74939181061030
• Device Catalogue Number: 39181-06103
• Device Lot Number: 17255657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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: ZIPWIRE
• Patient Age: 77 YR