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

Lot Number 0024500977

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.

Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred.Vascular access was obtained via radial approach.The target lesion was located in the severely tortuous distal right coronary artery.Pre-dilatation was performed with a non-bsc balloon and a 38x2.50mm promus elite drug-eluting stent was advanced for treatment.During deployment it was noted that the distal portion of the stent did not fully expand due to calcification.The physician dilated the stent balloon twice to 20 atmospheres to try to expand the distal part of the stent but it was still unable to expand.The physician attempted to remove the stent catheter but the it could not be removed.He then pulled the device harder but the stent catheter broke.The physician switched to groin access and used a new guidezilla 6fr to attempt to balloon the catheter free but it failed.He tried to snare the catheter but it failed as well.Finally, a non-bsc wire was used but the wire was unable to entagle the catheter and the patient was taken to the operating room.

Manufacturer Narrative

(a2) age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: p elite us mr 38 x 2.50 mm stent delivery system was returned for analysis without the distal section containing the inner/outer shaft polymer extrusion, balloon and stent.A visual examination of the stent, balloon, tip profiles and distal end of the shaft polymer extrusion profile could not be completed as the device was returned without these sections.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 in the midshaft region of the shaft polymer extrusion measured at 12.3 cm distal to the midshaft-hypotube bond.No other issues were identified during the product analysis.

Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred.Vascular access was obtained via radial approach.The target lesion was located in the severely tortuous distal right coronary artery.Pre-dilatation was performed with a non-bsc balloon and a 38x2.50mm promus elite drug-eluting stent was advanced for treatment.During deployment it was noted that the distal portion of the stent did not fully expand due to calcification.The physician dilated the stent balloon twice to 20 atmospheres to try to expand the distal part of the stent but it was still unable to expand.The physician attempted to remove the stent catheter but the it could not be removed.He then pulled the device harder but the stent catheter broke.The physician switched to groin access and used a new guidezilla 6fr to attempt to balloon the catheter free but it failed.He tried to snare the catheter but it failed as well.Finally, a non-bsc wire was used but the wire was unable to entangle the catheter and the patient was taken to the operating room.

• Brand Name: PROMUS ELITE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9477809
• MDR Text Key: 171648955
• Report Number: 2134265-2019-15726
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Lot Number: 0024500977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention