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

Model Number	H7493952838400
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: 2134265-2016-10215.It was reported that catheter removal difficulties were encountered.The target lesion was located in the proximal saphenous vein.After a 4.00x38mm promus premier¿ stent was deployed, the physician attempted to retrieve the balloon into the guide; however, it was noted that the balloon was unable to rewrap correctly and there was a lot of wasting.The device got caught up on the guide and had to pull the whole system out.Subsequently, the physician rewired the artery and attempted to advance a 4.00 x 16 synergy ii drug-eluting stent but failed to cross the previously implanted stent.There was a lot of force applied and when the physician tried to retrieve the synergy¿ stent all the way through up to the groin, the stent got dislodged in the groin.The physician was then able to retrieve the stent through the arteriotomy of the femoral artery with a hemostats and a mini cut down that was right at the mouth of the whole artery.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6101405
• Report Number: 2134265-2016-10214
• Device Sequence Number: 16215119
• Product Code: NIQ
• UDI-Device Identifier: 08714729845041
• UDI-Public: (01)08714729845041(17)20170227(10)0018375532
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/21/2016

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: 02/27/2017
• Device Model Number: H7493952838400
• Device Catalogue Number: 39528-3840
• Device Lot Number: 0018375532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2016
• Initial Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1