MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RP ENDOPROSTHESIS; STENT, CORONARY

Model Number	M001712380
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is indicated that the device will not be returned for evaluation.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 the product was mislabeled.The target lesion was located in the iliac artery.A 10x69x75 wallstent¿ rp endoprosthesis was selected to treat the lesion.During advancing into the introducer sheath, it was noted that the stent was flawed as it was much longer than what was labeled.The actual stent length measured at 130mm.The stent was deployed as there was no spare stent for replacement.No patient complications were reported.
Additional Manufacturer Narrative
Describe event or problem was corrected from ¿the target lesion was located in the iliac artery¿ to ¿the target lesion was located in the iliac vein.¿ (b)(4).
Event or Problem Description
It was corrected that the target lesion was located in the iliac vein.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6907507
• Report Number: 2134265-2017-09710
• Device Sequence Number: 505684
• Product Code: MAF
• UDI-Device Identifier: 08714729345923
• UDI-Public: 08714729345923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 07/07/2018
• Device Model Number: M001712380
• Device Catalogue Number: 71-238
• Device Lot Number: 0019451680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1