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

Model Number 10668

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: promus select ous mr 38 x 3.00mm stent delivery system was returned for analysis.Device returned with mandrel and stent protector attached.Mandrel could not be removed, device placed in water bath to soak.Mandrel and stent protector were easily removed from device after soaking.An examination of the crimped stent identified proximal stent damage with stent struts lifted and pulled distally.The undamaged crimped stent outer diameter was 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 multiple kinks.A examination of the shaft polymer extrusion found no issues.An examination of the tip found no issues.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 24jun2020.It was reported that crossing difficulties were encountered.The 38mmx3mm target lesion was located in the partially calcified right coronary artery.A 38 x 3.00 promus premier select drug eluting stent was advanced but failed to cross the lesion.The device was removed and the procedure was completed with another of the same device.No patient complications nor injuries were reported.However, returned device analysis revealed stent damage.

• Brand Name: PROMUS PREMIER SELECT
• 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: 10224854
• MDR Text Key: 197333677
• Report Number: 2134265-2020-08631
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 10668
• Device Catalogue Number: 10668
• Device Lot Number: 0023922860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2019
• 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