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

Model Number 9553

Device Problem Positioning Failure (1158)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The promus premier ous mr 32 x 2.25mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of distal stent damage with stent struts bunched proximally.The undamaged crimped stent outer diameter was measured and the result is 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 found distal tip 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.The device was soaked over-night at 37 degrees to facilitate functional testing.A recommended 0.014 guidewire was loaded successfully before the functional test.The balloon was inflated to rated burst pressure without issue, maintained pressure and the stent expanded successfully despite the stent damage.The device was deflated successfully in 11 seconds which is within deflation time specification.The inflation device was verified before and after use.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 24-jun-2021.It was reported that deployment failure occurred.The patient presented with myocardial infarction.The stenosed, 32 x 2.40mm target lesion was located in the mildly calcified and moderately tortuous distal left anterior descending artery.A 32 x 2.25mm promus premier drug-eluting stent was advanced but the stent was unable to expand.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed stent damage.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12142839
• MDR Text Key: 260709174
• Report Number: 2134265-2021-08783
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0025638238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• 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: 72 YR
• Patient Weight: 81