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

Model Number 10666

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: p select ous mr 28 x 3.50mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the proximal end of the stent were lifted and bunched distally.The undamaged stent outer diameter was measured 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 shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found issues.The mid-shaft section was stretched along its length with a kink 185mm distal of the midshaft weld.The shaft polymer extrusion was stretched from the port weld extending 5mm distally.Additionally, the distal inner lumen was stretched and bunched 2mm distal of the bi-component bond extending 5mm distally.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 17 sep 2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed, 3.5mm x 28mm, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and mildly calcified ramus intermedius artery.After pre-dilatation was performed, a 28 x 3.50 promus premier select drug-eluting stent was advanced but the physician had difficulties in crossing the lesion.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a 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: 10646744
• MDR Text Key: 210363140
• Report Number: 2134265-2020-13173
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0023843882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• 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