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

Model Number 9553

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the radial artery.The 30mmx3.5mm, de novo, eccentric target lesion containing a >45 and <90 degrees bend was located in the moderately tortuous and severely calcified right coronary artery.After the lesion was crossed with a 0.014 non-boston scientific guidewire, pre-dilatation was performed with 2.5x20 and 3x15 sc balloon catheters.Following pre-dilatation, a 32 x 3.50 promus premier drug-eluting stent was advanced for treatment.However, during the procedure, the device was stuck and failed to advance.Subsequently, a 3.5x12 nc balloon catheter was used and advanced the stent again but some of the stent sells was damaged.The procedure was completed with another smaller stent.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus premier ous mr 32 x 3.50mm stent delivery system catheter was returned for analysis.Examination of the crimped stent via scope found evidence of proximal stent damage with strut bunching.The undamaged crimped stent outer diameter was measured, and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations 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 no issues.The device could not be loaded on test guidewire due to solidified media in the lumen.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the radial artery.The 30mmx3.5mm, de novo, eccentric target lesion containing a >45 and <90 degrees bend was located in the moderately tortuous and severely calcified right coronary artery.After the lesion was crossed with a 0.014 non-boston scientific guidewire, pre-dilatation was performed with 2.5x20 and 3x15 sc balloon catheters.Following pre-dilatation, a 32 x 3.50 promus premier drug-eluting stent was advanced for treatment.However, during the procedure, the device was stuck and failed to advance.Subsequently, a 3.5x12 nc balloon catheter was used and advanced the stent again but some of the stent sells was damaged.The procedure was completed with another smaller stent.There were no patient complications reported and the patient status was stable.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 12708686
• MDR Text Key: 278795337
• Report Number: 2134265-2021-13508
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0024784676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 80 KG