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

Model Number	H7493952832250
Medical Device Problem Codes	Bent (1059); Entrapment of Device (1212)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage and catheter entrapment occurred.The target lesion was located below the knee vessel.A 2.50x32mm promus premier¿ drug-eluting stent was selected for use to treat the lesion.However, as the stent was loaded onto the wire, outside of the body, it would no longer advance on the wire.The proximal end of the stent crumpled on the balloon.The physician attempted to remove the entire delivery system from the wire as it had not entered the patient¿s body but was unable to.The entire stent delivery system was removed from the wire after a blade was used to strip the stent off the balloon.The procedure was completed with a new promus premier stent.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6118460
• Report Number: 2134265-2016-10385
• Device Sequence Number: 623702
• Product Code: NIQ
• UDI-Device Identifier: 08714729844952
• UDI-Public: (01)08714729844952(17)20170712(10)0018824251
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/26/2016

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: 07/12/2017
• Device Model Number: H7493952832250
• Device Catalogue Number: 39528-3225
• Device Lot Number: 0018824251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1