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

Model Number	9589
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: promus premier us mr 4.00 x 38.00 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and the proximal balloon cone was noted to be slightly relaxed.However, 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 several kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found a break in the mid shaft section of the device at 115.5 cm distal to the distal end of the strain relief with the corewire visibly bent.The device failed to inflate due to break in the mid-shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that balloon inflation failure and shaft kink occurred.The target lesion was located in the distal right coronary artery.A 4.00x38mm promus premier drug-eluting stent was advanced for dilatation.However, it was noted that the shaft kinked and the balloon was unable to inflate the stent.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed shaft detached.

• Brand Name: PROMUS PREMIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9628938
• Report Number: 2134265-2020-00325
• Device Sequence Number: 2913936
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: 08714729845041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2020
• Device Model Number: 9589
• Device Catalogue Number: 9589
• Device Lot Number: 0023834425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1