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

Model Number	H7493952820300
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.During the unpacking of a 3.00x20 mm promus premier¿ drug-eluting stent, the stent shaft broke when the device was removed from the packaging hoop.The device never entered the patient's body.The procedure was completed with the implantation of a 3.0x12 mm promus drug-eluting stent, deployed at 16 atmospheres for 8 seconds, followed by post-dilatation with a 3.5x8 mm nc quantum balloon catheter.No patient complications were reported and the patient's status was okay.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier mr us 3.00 x 20mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and was within the maximum crimped stent profile.The bumper tip of the device was examined and no issues were noted.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.An examination of the shaft polymer extrusion found a break in the midshaft at approximately 5.8cm distal of the hypotube/midshaft bond.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
During the unpacking of a 3.00x20mm promus premier drug-eluting stent, the stent shaft broke when the device was removed from the packaging hoop.The device never entered the patient's body.The procedure was completed with the implantation of a 3.0x12mm promus drug-eluting stent, deployed at 16 atmospheres for 8 seconds, followed by post-dilatation with a 3.5x8mm nc quantum balloon catheter.No patient complications were reported and the patient's status was okay.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6296544
• Report Number: 2134265-2017-00451
• Device Sequence Number: 443074
• Product Code: NIQ
• UDI-Device Identifier: 08714729844792
• UDI-Public: (01)08714729844792(17)20171113(10)19293035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/12/2017

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: 11/13/2017
• Device Model Number: H7493952820300
• Device Catalogue Number: 39528-2030
• Device Lot Number: 19293035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR