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

Model Number 9386

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in the severely tortuous and severely calcified left coronary artery diagonal branch segment.The lesion was engaged with a jr4.0 guide catheter and crossed with a guide wire.Dilatation was performed with a 2.0x15mm balloon and a 2.25x20mm promus element plus drug-eluting stent was advanced for treatment.However, it was observed that the tip of the stent struts were lifted up after several attempts due to severe calcification.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in the severely tortuous and severely calcified left coronary artery diagonal branch segment.The lesion was engaged with a jr4.0 guide catheter and crossed with a guide wire.Dilatation was performed with a 2.0x15mm balloon and a 2.25x20mm promus element plus drug-eluting stent was advanced for treatment.However, it was observed that the tip of the stent struts were lifted up after several attempts due to severe calcification.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus element plus,mr,ous 2.25 x 20mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with mid-section and distal end struts lifted.The undamaged crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.The balloon cones were 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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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: 11187946
• MDR Text Key: 227544709
• Report Number: 2134265-2021-00428
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 9386
• Device Catalogue Number: 9386
• Device Lot Number: 0025587770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: JR4.0; GUIDE CATHETER: JR4.0
• Patient Age: 70 YR
• Patient Weight: 78