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

Model Number 9547

Device Problems Break (1069); Deflation Problem (1149); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that balloon deflation failure and shaft break occurred.An 8 x 4.00 promus premier drug-eluting stent was advanced to treat a lesion.However, the stent delivery balloon would not deflate, would not enter the guide, and would not re-inflate.When the device was attempted to be removed, the shaft broke.The two broken pieces were successfully recovered.No patient complications were reported.

Manufacturer Narrative

Device is a combination product.Device evaluated by manufacturer: a promus premier ous mr 8 x 4.00mm stent delivery system was returned for analysis.There was no stent attached or returned.The balloon appeared to have been inflated and deflated.An inflation/deflation test could not be carried out due to damage in the shaft polymer extrusion.Visual and microscopic examination of the bumper tip showed damage.Visual and tactile examination of the hypotube found multiple kinks.Visual and tactile examination of the outer and inner lumen and mid-shaft section found a break in the mid-shaft extrusion 1230mm distal to the distal end of the strain relief.A kink was noted at the site of the wire exchange port.Shaft polymer extrusion stretching was noted for 6mm on the distal side of the wire exchange port and the wire exchange port was damaged.Multiple sites of inner and outer shaft polymer extrusion bunching was noted.Inner shaft polymer extrusion stretching noted 2mm distal to the bicomponent bond.The distal section of the device was returned on a 0.014'' guidewire extending from the wire exchange port, the device was stuck on the guidewire.The device was placed in a waterbath, but the wire still could not be removed.It appeared that the wire could not be removed due to shaft polymer extrusion bunching and stretching.No other issues were identified during the product analysis.

Event Description

It was reported that balloon deflation failure and shaft break occurred.An 8 x 4.00 promus premier drug-eluting stent was advanced to treat a lesion.However, the stent delivery balloon would not deflate, would not enter the guide, and would not re-inflate.When the device was attempted to be removed, the shaft broke.The two broken pieces were successfully recovered.No patient complications were reported.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8315759
• MDR Text Key: 135382873
• Report Number: 2134265-2019-00806
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: 9547
• Device Catalogue Number: 9547
• Device Lot Number: 0022206842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 03/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1