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

Model Number H74939180064070

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent deployment, dislodgement issue and fracture occurred.Vascular access was obtained via contralateral approach from the right femoral artery.The target lesion was located in the superficial femoral artery (sfa).Following the insertion of a 6f non-bsc introducer sheath and a guide wire, a 6x40x75 innova stent was advanced to treat the lesion.In addition, a second small 014 guide wire was advanced through the sheath and lodged in the profunda.However, as the innova stent was being advanced through the sheath, resistance was encountered and the sheath prolapsed out of the right common iliac artery.At this point, the stent was noted to have separated from the deployment catheter and was resting in the abdominal aorta.The innova stent deployment mechanism remained locked with the yellow stopper still in place.Subsequently, the innova stent delivery catheter was removed from the patient's body and was inspected and no abnormalities were detected.The yellow stopper was then removed and the thumbwheel was rotated to check the operation of the deployment mechanism which operated without any abnormalities.It was also then confirmed that the stent was missing from the delivery catheter when it was fully retracted.The innova stent was eventually pulled back into the common iliac artery with the assistance of an inferior vena cava (ivc) filter and sheath, and then with an endo snare.The stent fractured during the removal attempts and the remaining stent was removed via an open endarterectomy.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer shaft, inner shaft, proximal liner and the remainder of the device were checked for damage.The outer shaft was kinked at the nosecone.The middle shaft was damaged in 2 places, 1 at 15cm from the tip and the other at 17cm from the tip.The inner shaft was kinked 6cm from the tip.The stent was returned and was fractured.The pull rack was also separated from the handle.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 deployment, dislodgement issue and fracture occurred.Vascular access was obtained via contralateral approach from the right femoral artery.The target lesion was located in the superficial femoral artery (sfa).Following the insertion of a 6f non-bsc introducer sheath and a guide wire, a 6x40x75 innova¿ stent was advanced to treat the lesion.In addition, a second small 014 guide wire was advanced through the sheath and lodged in the profunda.However, as the innova¿ stent was being advanced through the sheath, resistance was encountered and the sheath prolapsed out of the right common iliac artery.At this point, the stent was noted to have separated from the deployment catheter and was resting in the abdominal aorta.The innova¿ stent deployment mechanism remained locked with the yellow stopper still in place.Subsequently, the innova¿ stent delivery catheter was removed from the patient's body and was inspected and no abnormalities were detected.The yellow stopper was then removed and the thumbwheel was rotated to check the operation of the deployment mechanism which operated without any abnormalities.It was also then confirmed that the stent was missing from the delivery catheter when it was fully retracted.The innova¿ stent was eventually pulled back into the common iliac artery with the assistance of an inferior vena cava (ivc) filter and sheath, and then with an endo snare.The stent fractured during the removal attempts and the remaining stent was removed via an open endarterectomy.

• 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: 5781908
• MDR Text Key: 49146922
• Report Number: 2134265-2016-06385
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

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: 06/30/2018
• Device Model Number: H74939180064070
• Device Catalogue Number: 39180-06407
• Device Lot Number: 18074205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• 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
• Treatment: 014 GUIDEWIRE
• Patient Outcome(s): Required Intervention