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

Model Number	M001712180
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that stent profile problem occurred.The 80% stenosed target lesion was located in a shunt in the moderately tortuous, mildly calcified, and 7 mm in diameter brachial vein.An 8x38x75/ iliac 6f wallstent¿ rp endoprosthesis was advanced to treat the lesion.However, it was noted during deployment that the length of the stent was about 1 cm.The procedure was completed with additional wallstent placed.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that stent profile problem occurred.The 80% stenosed target lesion was located in a shunt in the moderately tortuous, mildly calcified, and 7mm in diameter brachial vein.An 8x38x75/ iliac 6f wallstent¿ rp endoprosthesis was advanced to treat the lesion.However, it was noted during deployment that the length of the stent was about 1cm.The procedure was completed with additional wallstent placed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent of the returned device was not returned for analysis as it was implanted in the patient.As per dfu ¿ wallstent¿ rp endoprosthesis, iliac, the size of the stent that is mounted on the returned device before deployment is 38mm.When deployed in a vessel of 7mm the implanted length of the stent is approximately 57mm.A visual and microscopic examination identified no issues with the markerbands.The position of the markerbands were measured as the stent is cut and placed using the markerbands as guidance.The markerbands were noted to be within specification.No issues were noted with the markerbands that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issue along the length of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7588185
• Report Number: 2134265-2018-05246
• Device Sequence Number: 1946443
• Product Code: MAF
• UDI-Device Identifier: 08714729345749
• UDI-Public: 08714729345749
• Combination Product (Y/N): N
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2019
• Device Model Number: M001712180
• Device Catalogue Number: 71-218
• Device Lot Number: 20239484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: MEDIKIT 6FR; GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: MEDIKIT 6FR
• Outcome Attributed to Adverse Event: Required Intervention