MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING

Model Number 10676

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent damage occurred and removal difficulties were encountered.A 32x4.00mm promus elite drug-eluting stent was selected for use to treat the lesion.However, while delivering the device in a guide catheter, the stent got damaged and it became stuck in the tip of the guide catheter.The physician had difficulty removing the stent from the guide and had to cut the stent from the delivery system.The device was removed and a 4x38mm promus elite fdrug-eluting stent was used and completed the procedure.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred and removal difficulties were encountered.A 32x4.00mm promus elite drug-eluting stent was selected for use to treat the lesion.However, while delivering the device in a guide catheter, the stent got damaged and it became stuck in the tip of the guide catheter.The physician had difficulty removing the stent from the guide and had to cut the stent from the delivery system.The device was removed and a 4x38mm promus elite drug-eluting stent was used and completed the procedure.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: p elite ous mr 32 x 4.00 mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the proximal stent region were lifted, pulled on the balloon body in a distal direction and bunched in the mid-stent region of the stent.The undamaged stent od was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The stent was lifted from the balloon and bunched in the mid stent region exposing the balloon wall where crimp markings were visible.However, the balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a break/cut in the inner/outer shaft polymer extrusion situated at 133.5 cm distal to the distal end of strain relief.No other issues were identified during the product analysis.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9314657
• MDR Text Key: 166190976
• Report Number: 2134265-2019-13443
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: 10676
• Device Catalogue Number: 10676
• Device Lot Number: 0023897918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention