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

Model Number	H74939293072030
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: over 18 years.(b)(4).Device evaluated by mfr.: returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 guidewire stuck in the device.The outer shaft, mid-shaft and the remainder of the device were checked for damage.The handle was opened from the customer site when returned.There was a.014 guidewire stuck in the device.The.014 guidewire was protruding from the tip 31cm.The guidewire was protruding from the proximal end of the device 109cm.Visual examination showed buckling on the outer sheath approximately 47cm and 54cm from the nosecone.The mid-shaft showed a kink at the retainer clip.The proximal inner was severely prolapsed.The pull handle was damaged on the 1st tooth.The thumbwheel showed minor damage on the teeth.The stent was not returned so the alleged damage could not be confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.The innova states that a stiff 0.035 in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery.(b)(4).
Event or Problem Description
It was reported that the stent partially deployed and stretched.A contralateral approach was used to access the approximately 70% stenosed target lesion located in the moderately calcified and moderately tortuous left superficial femoral artery (sfa).A.014 thruway 300cm guidewire was advanced and a 45cm 7fr sheath was placed.Pre-dilation was performed with a 6x200 balloon.A 7 x 200 x 130 innova¿ stent was advanced to the lesion and deployment was initiated.The thumbwheel was used until the white arrow was visible.After about 100mm, deployment stopped and it would not move.The pull grip was attempted to complete deployment, but it would not move and was stuck.The handle was cracked open to attempt manual deployment, but this was unsuccessful.The physician pulled on the device to remove the device from the patient.During this attempt, the stent deployed but was stretched.The procedure was completed with other stents.Two 6x150 non-bsc stents were placed over the innova.The patient was fine and there were no complications.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported the innova catheter and the 014 thruway guidewire became stuck during use in the patient and the innova catheter and wire were removed as a unit.

• 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: 7041386
• Report Number: 2134265-2017-11178
• Device Sequence Number: 2144206
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: 08714729874157
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 09/30/2019
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 19693528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92169170-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention