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

Model Number 10674

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/22/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 24 x 2.50 promus elite drug-eluting stent was selected for use.However, during preparation, the catheter of the stent delivery system was found to be broken.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that shaft break occurred.A 24 x 2.50 promus elite drug-eluting stent was selected for use.However, during preparation, the catheter of the stent delivery system was found to be broken.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the device was broken during removal from the carrier coil tube.

Manufacturer Narrative

Device evaluated by mfr.: a promus elite ous mr 24 x 2.50mm stent delivery system was returned for analysis without the carrier hoop.An examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found a break 2mm distal to the distal end of the strain relief.Examination of the break site via scope found that the hypotube appeared to have been bent at the break site, as evident by the curved oval shaped appearance of the hypotube on both sides of the break.An examination of the shaft polymer extrusion found no issues.An examination of the tip found no issues.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: 10547375
• MDR Text Key: 207345471
• Report Number: 2134265-2020-12099
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: 04/30/2021
• Device Model Number: 10674
• Device Catalogue Number: 10674
• Device Lot Number: 0023767832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/23/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70