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

Model Number	9588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 was used as event date, since there was no event date reported.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 4.00x32mm promus premier drug-eluting stent was advanced to treat the lesion.However, it was noted that the shaft broke.No patient complications were reported.
Additional Manufacturer Narrative
On (b)(6) 2018 was used as event date, since there was no event date reported.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 4.00x32mm promus premier drug-eluting stent was advanced to treat the lesion.However, it was noted that the shaft broke.No patient complications were reported.The device was returned for evaluation.A visual examination of the stent found damage to the distal stent rows 1, 3, 7 and 9 with the stent struts lifted slightly.The undamaged crimped stent outer diameter was measured and noted to be within specification.A visual and microscopic examination of the of the bumper tip found no signs of damage.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 tactile examination of the device found a break in the hypotube 790mm distal from the distal end of the strain relied.Multiple hypotube kinks were also noted along the full length of the catheter.A visual and tactile examination of the shaft polymer extrusion found multiple midshaft kinks along the catheter.No other issues were identified during the product analysis.

• 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: 7851127
• Report Number: 2134265-2018-60743
• Device Sequence Number: 1835968
• Product Code: NIQ
• UDI-Device Identifier: 08714729844990
• UDI-Public: 08714729844990
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 07/10/2019
• Device Model Number: 9588
• Device Catalogue Number: 9588
• Device Lot Number: 0021619359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1