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

Model Number 10666

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that a balloon rupture occurred.This 28 x 3.00 promus premier select was used for a procedure in a target lesion in the left anterior descending artery.When the stent was inflated, the stent did not deploy and the balloon burst.The device was replaced and the procedure was successfully completed.The patients status is stable.

Manufacturer Narrative

E1:initial reporter address 1 - (b)(6).Device evaluated by mfr: a 28 x 3.00mm promus select stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the proximal region of the stent were noted to be lifted and pulled in a distal direction.The undamaged stent od (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 signs of distal tip damage.A visual and tactile examination of the hypotube found multiple kinks along several location of the hypotube shaft.A visual and tactile examination of the outer and mid shaft section found a tear in the shaft polymer extrusion located at the guidewire exchange port and measured at 24.8cm proximal to the distal tip and extending for 0.4cm.The device was attempted to be inflated to 16atm, however this attempt failed due to pressure being lost in the inflation device as inflation liquid was seen leaking trough the tear on the shaft polymer extrusion.The encore inflation device was verified before and after use.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.This 28 x 3.00 promus premier select was used for a procedure in a target lesion in the left anterior descending artery.When the stent was inflated, the stent did not deploy and the balloon burst.The device was replaced and the procedure was successfully completed.The patients status is stable.

• 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
• MDR Report Key: 10559928
• MDR Text Key: 207720074
• Report Number: 2134265-2020-12987
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0025310012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1