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

Model Number	H7493952832400
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-02449.It was reported that stent damage occurred.The target lesion was located in the right coronary artery.After a 6f jr4 runway guide catheter was in place, a 4.00x12mm promus premier¿ drug-eluting stent was advanced but it was noted that the stent got caught with the guide catheter and was damaged.The device was removed and a 4.00x32mm promus premier¿ drug-eluting stent was then advanced; however, the stent got caught with the guide catheter and the physician felt that the second stent was damaged as well.The guide catheter was pulled out and a new guide catheter was then utilize to successfully deploy the stents.No patient complications were reported and the patient's status was great.
Additional Manufacturer Narrative
Device evaluated by mfr: promus premier us mr 4.00 x 32mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.The mid-section of the stent was damaged and bunched causing the proximal end of the stent to move on the balloon 2mm distally.The distal end of the stent was still in the crimped position and was within max 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 tactile examination of the device revealed no issues with the hypotube.An examination of the shaft polymer extrusion revealed damage to the inner.The inner shaft polymer extrusion was bunched 3mm distal from the bi-component bond.The tip was visually examined and no issues were noted.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2018-02449.It was reported that stent damage occurred.The target lesion was located in the right coronary artery.After a 6f jr4 runway guide catheter was in place, a 4.00x12mm promus premier drug-eluting stent was advanced but it was noted that the stent got caught with the guide catheter and was damaged.The device was removed and a 4.00x32mm promus premier drug-eluting stent was then advanced; however, the stent got caught with the guide catheter and the physician felt that the second stent was damaged as well.The guide catheter was pulled out and a new guide catheter was then utilize to successfully deploy the stents.No patient complications were reported and the patient's status was great.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7396303
• Report Number: 2134265-2018-02450
• Device Sequence Number: 10772134
• Product Code: NIQ
• UDI-Device Identifier: 08714729844990
• UDI-Public: 08714729844990
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/07/2018

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: 01/13/2019
• Device Model Number: H7493952832400
• Device Catalogue Number: 39528-3240
• Device Lot Number: 0020941225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1