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

Model Number 9388

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left anterior descending artery.A 3.50 x 24mm promus element plus drug-eluting stent was advanced but failed to cross the lesion and it was noticed that the stent struts were damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus element plus, mr, ous 3.50 x 24 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using a snap gauge and the result was within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left anterior descending artery.A 3.50x24mm promus element plus drug-eluting stent was advanced but failed to cross the lesion and it was noticed that the stent struts were damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the lesion was 80% stenosed, non-tortuous and mildly calcified.The lesion was pre-dilated with a bsc balloon catheter.

Event Description

It was reported that stent damage occurred.The stenosed target lesion was located in the left anterior descending artery.A 3.50x24mm promus element plus drug-eluting stent was advanced but failed to cross the lesion and it was noticed that the stent struts were damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Corrections: (d4) lot number corrected from 0025055675 to 0024512623.(d4) expiration date corrected from 01/14/2022 to 09/15/2021.(h4) device manufacture date corrected from 01/15/2020 to 09/16/2019.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10464166
• MDR Text Key: 204681754
• Report Number: 2134265-2020-11923
• 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,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: 9388
• Device Catalogue Number: 9388
• Device Lot Number: 0024512623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 56