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

Model Number 26924

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

It was reported that the catheter broke.A 8x20x130 innova vascular stent was selected for use during a patient iliac stent procedure.A non-bsc.035 wire was selected and the innova stent delivery system (sds) was then advanced on the wire.However, during advancement while outside the patient, the catheter became stuck on the wire and could not be removed.While trying to pull the sds off of the wire, it was thought that the catheter became broken.In hopes to maintain wire position within the patient, the physician deployed the stent outside the body.The physician hoped that the release of the stent would loosen up the sds and allow it to be removed from the wire, but the device remained stuck.Ultimately everything was removed from the patient and another wire and a longer stent were used to complete the procedure.The innova sds and stent was never introduced into the patient.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent system with a 0.035 guidewire inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner is separated into three pieces.The first piece measuring from the tip to the separation is approximately 9cm long.This piece is stuck to the guidewire and does not move.The second piece is approximately 9.7cm long and the third is approximately 9.6cm long.These two pieces can slide back and forth along the guidewire.There is a kink at the nosecone.Microscopic examination revealed that the inner liner is stretched 4.7cm from the tip and goes to the separation.The rack is deployed 4.8cm from the handle.The proximal inner is extending 2.8cm from the distal end of the middle sheath.The stent was deployed and did not return with the device.There is blood present inside the inner liner and proximal inner.The guidewire was pulled and was able to be removed from the device.The guidewire was inserted back into the device and was able to be inserted all the way to where the stuck inner liner is located.The guidewire could be seen exiting the proximal end of the device.From the proximal end of the guidewire to the proximal end of the stuck inner liner is approximately 199cm.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirm the froze on wire and the separation of the inner liner.

Event Description

It was reported that the catheter broke.A 8x20x130 innova vascular stent was selected for use during a patient iliac stent procedure.A non-bsc.035 wire was selected and the innova stent delivery system (sds) was then advanced on the wire.However, during advancement while outside the patient, the catheter became stuck on the wire and could not be removed.While trying to pull the sds off of the wire, it was thought that the catheter became broken.In hopes to maintain wire position within the patient, the physician deployed the stent outside the body.The physician hoped that the release of the stent would loosen up the sds and allow it to be removed from the wire, but the device remained stuck.Ultimately everything was removed from the patient and another wire and a longer stent were used to complete the procedure.The innova sds and stent was never introduced into the patient.No patient complications were reported.Device evaluated by manufacturer: the returned product consisted of an innova self-expanding stent system with a 0.03 inch guidewire inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner is separated into three pieces.The first piece measuring from the tip to the separation is approximately 9cm long.This piece is stuck to the guidewire and does not move.The second piece is approximately 9.7cm long and the third is approximately 9.6cm long.These two pieces can slide back and forth along the guidewire.There is a kink at the nosecone.Microscopic examination revealed that the inner liner is stretched 4.7cm from the tip and goes to the separation.The rack is deployed 4.8cm from the handle.The proximal inner is extending 2.8cm from the distal end of the middle sheath.The stent was deployed and did not return with the device.There is blood present inside the inner liner and proximal inner.The guidewire was pulled and was able to be removed from the device.The guidewire was inserted back into the device and was able to be inserted all the way to where the stuck inner liner is located.The guidewire could be seen exiting the proximal end of the device.From the proximal end of the guidewire to the proximal end of the stuck inner liner is approximately 199cm.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8404807
• MDR Text Key: 138271037
• Report Number: 2134265-2019-02154
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874164
• UDI-Public: 08714729874164
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022718690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPRACORE .035 WIRE- ABBOTT; SUPRACORE .035 WIRE- ABBOTT; SUPRACORE .035 WIRE- ABBOTT