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

Model Number H74939181062030

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 09/29/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that deployment issues and death occurred.The target lesion was located in the superficial femoral artery (sfa).It was noted that a bypass at the sfa was not possible.Additionally, an antegrade approach was not possible, therefore the physician attempted to crossover with additional retrograde access.The bifurcation was noted to be very tortuous.A non bsc sheath was placed in the sfa and a non bsc stent was advanced, but could not pass through the sheath.The 6x200x130 innova stent was then advanced to the lesion.The first portion of the stent was deployed using the thumbwheel.Further deployment was attempted with the pull grip; however, the pull grip broke while the stent was partially deployed.It was noted that the sheath was likely bent sharply due to the length of the procedure and subsequently bent the shaft of the innova.They attempted to open the handle and resolve the issue, but this was not successful.The stent could not be fully deployed.While transferring to surgery, the patient experienced cardiogenic shock due to myocardial infarction and died.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an innova device in two (2) pieces.Only the left half of the handle was received.Inspection revealed no gross damage to the handle or internal components.Blood was present on the outside and inside of the shaft.Microscopic examination revealed numerous locations with buckled shaft material in the outer shaft.The middle sheath detached was from the retainer with the retainer clip still bonded to the rack.Microscopic examination o the inner shaft showed the tip to be detached and not included with the returned product.No stent was returned with the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported deployment difficulty.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was further reported the sheath used was a 6f.The stent was about 1/3 deployed when the physician attempted to use the pullgrip.The stent remained partially deployed when the patient was transferred to surgery.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5189157
• MDR Text Key: 29887665
• Report Number: 2134265-2015-07304
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939181062030
• Device Catalogue Number: 39181-06203
• Device Lot Number: 18151350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 86 YR