MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293062030
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that deployment difficulties were encountered and a stent fracture occurred.The target lesion was located in the superficial femoral artery (sfa).A 6x200x130 innova¿ stent was advanced to treat the lesion.Stent deployment was initiated via the thumbwheel; however, the thumbwheel stopped clicking.The pull grip was also attempted manually but the stent did not deploy.The innova¿ stent eventually fractured.Attempts were made to retrieve the fractured stent with a snare; however, these were unsuccessful.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: an innova self-expanding stent delivery system was returned and the outer shaft, mid-shaft and the remainder of the device were checked for damage.Visual examination showed buckling at the nosecone and approximately 70 to 72cm from the tip.The handle was separated when received.The mid-shaft showed no damage.The mid-shaft was separated from the retainer clip.The inner liner was kinked and also the proximal inner was separated from the clip.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.(b)(4).
Event or Problem Description
It was reported that deployment difficulties were encountered and a stent fracture occurred.The target lesion was located in the superficial femoral artery (sfa).A 6x200x130 innova stent was advanced to treat the lesion.Stent deployment was initiated via the thumbwheel; however, the thumbwheel stopped clicking.The pull grip was also attempted manually but the stent did not deploy.The innova stent eventually fractured.Attempts were made to retrieve the fractured stent with a snare; however, these were unsuccessful.No further patient complications were reported.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6698925
• Report Number: 2134265-2017-06580
• Device Sequence Number: 11277654
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20190831(10)0019641826
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• 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,Followup
• Report Date (Section B): 06/15/2017

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: 08/31/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 0019641826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention