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

Model Number 9551

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus premier ous mr 24 x 4.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent struts in proximal and mid-regions were pulled distally.The undamaged stent outer diameter was measured by snap gauge and the result is 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 hypotube kink located at 51.3cm distal to the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination found no issues with the tip.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 06-apr-2020.It was reported that advancing difficulties were encountered.The 80-90% diffuse stenosis was located in the tortuous left anterior descending artery.After crossing the lesion with a guidewire, pre-dilation was performed with a 3.5x20mm balloon showing alleviation of stenosis.A 24 x 4.00mm promus premier drug-eluting stent was advanced several times but had difficulty placing in the lesion due to tortuosity.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and 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: 10006352
• MDR Text Key: 189621179
• Report Number: 2134265-2020-04991
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0022451790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2018
• 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: 68 YR
• Patient Weight: 73