MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER

Model Number 10445

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: the reported sheath kink was confirmed.The reported insertion difficulty, difficulty advancing/removing ancillary device, vessel perforation and hemorrhage could not be confirmed via lab analysis as clinical circumstances could not be replicated.The returned product consisted of a 14f isleeve sheath.The tip of the device and 7.5cm of the sheath were pulled backwards into the proximal area of the sheath.The tip of the device and sheath were microscopically and visually inspected.Inspection revealed damage to the sheath which included numerous kinks, abrasions and crazing.The tip of the device had abrasions and was misshapen.Two of the three sheath seams were partially opened.The tip damage on the distal most end of the device is consistent with an ancillary device catching on the tip, thus being withdrawn backwards into the sheath.Procedural imaging and still images were provided to assist in the investigation.The procedural media was reviewed by a boston scientific medical safety director.In conclusion the media is consistent with allegation of damage to abdominal aorta (likely due to guide catheter) and damage to the distal part of the isleeve.There is also a mild residual pvl leak.There is no evidence of coronary obstruction by the valve, since the flow did not decrease after full valve deployment based on the recorded loops.It is more likely that the mi occurred in the context of severe existing cad aggravated by the procedural complications and likely hemodynamic instability.Two still images of the isleeve, once removed from patient and on table showed the tip is split and distal end is bunched up.

Event Description

It was reported that vessel perforation of the right femoral artery and retroperitoneal bleeding occurred.Procedure summary: the patient has a medical history of first-degree atrioventricular (av) block and coronary artery disease with previous unspecified stents implanted in the right coronary artery (rca).Vascular access was gained through the extremely small right femoral artery.The patients vasculature was severely stenotic with mild calcification and tortuosity.Resistance was felt during insertion of the 14f isleeve introducer sheath into the femoral artery.Once inserted, difficulty inserting an acurate neo2 valve loaded onto an acurate neo2 transfemoral delivery system (tf ds) was encountered, however the acurate neo2 valve system was able to be advanced and deployed in the native aortic annulus without issue.Resistance was encountered again when removing the acurate neo2 tf ds through the isleeve 14f introducer sheath however the acurate neo2 tf ds was able to be removed without issue.Angiograms were performed at the completion of the procedure and then the isleeve introducer sheath was removed from the patient.Upon removal of the isleeve introduce sheath two visible folds were noted on the sheath.There were no patient complications immediately following the procedure.Post procedure event summary: twenty four hours after the procedure, the patient suffered peritoneal bleeding.Computerized tomography (ct) revealed a small perforation in right femoral artery.No intervention was required as the bleeding spontaneously stopped on its own.The ct scan did not show any active bleeding.Additionally, the patient suffered complications of pericardial effusion and cardiac tamponade following a permanent pacemaker implant not related to the acurate neo2 valve implant.The acurate neo2 valve implant did not cause or worsen any conduction disturbances necessitating the pacemaker implant.Myocardial infarction occurred due to restenosis of the stents in the rca.An attempt at percutaneous coronary intervention of the rca was made, however the patient died.The cause of death was myocardial infarction.Per the physician the patient death was due to restenosis of the stented rca and not due to the transcatheter aortic valve implantation (tavi) procedure.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10906387
• MDR Text Key: 218743139
• Report Number: 2134265-2020-15832
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0025252118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR