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

Model Number H7493918412250

Device Problems Stent (515); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older. 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 Description

It was reported that stent dislodgement occurred. The target lesion was located in the severely tortuous and severely calcified right coronary artery (rca). A 2. 50x12mm promus element¿ plus drug-eluting stent was advanced but failed to cross the lesion. It was then noted that the stent was dislodged from the delivery system. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6194829
• MDR Text Key: 62985559
• Report Number: 2134265-2016-12358
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: CN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/15/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/21/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 06/05/2017
• Device MODEL Number: H7493918412250
• Device Catalogue Number: 39184-1225
• Device LOT Number: 18732821
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/10/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/21/2016 Patient Sequence Number: 1