MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SENTRANT INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	SENSH2228W
Medical Device Problem Codes	Difficult to Insert (1316); Difficult To Position (1467)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant sheath was used in a patient for the endovascular treatment of 300 mm in length thoracic dissection.It was reported that a percutaneous approach was performed from the left groin.Another manufacturer¿s sutures were placed and guidewire access was obtained.The first main valiant 32 x 32 x 200 stent graft was implanted without any sequelae.A 22fr sentrant sheath was inserted to backfill the hole, however was met with resistance and unable to advance to the intended landed location.The 22fr sentrant sheath was removed from the patient.A second valiant 34 x 30 x 150 stent graft was implanted.The 22 fr sheath was reinserted again to backfill the hole, however was met with resistance and unable to advance to the intended landed location.An angiogram was performed and the tevar for dissection was successfully covered.The physician removed the 22 sentrant sheath from the patient.A retrograde angiogram was performed through the left groin and extravagation was noted due to a perforation of the left common iliac artery (lcia).The physician inserted a 10 mm another manufacturer¿s balloon through the left groin to the proximal lcia.Then another manufacturer¿s 8 x 10 cm covered stent was implanted two cm below the aortic bifurcation.Then another manufacturer¿s 10 x 38 covered stent was implanted proximal to that, at the level of the proximal lcia.Then another manufacturer¿s 8 x 15 covered stent was implanted down to the access site.The physician surgically opened the groin and repaired the lcfa with a patch.An angiogram was performed and the perforation was resolved.Per the physician the cause of the perforation was due to the patient¿s anatomy of small in diameter access vessels.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the physician stated that the cause of the post-operative complications could not be determined.It was also noted that they were not related to the perforation of the left common iliac artery during the index procedure.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 6421642
• Report Number: 2953200-2017-00437
• Device Sequence Number: 13648149
• Product Code: DYB
• UDI-Device Identifier: 00643169150355
• UDI-Public: 00643169150355
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• 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,Followup
• Report Date (Section B): 04/17/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2018
• Device Model Number: SENSH2228W
• Device Catalogue Number: SENSH2228W
• Device Lot Number: 00120627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided; 04/17/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 05/09/2017; 10/02/2017
• 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
• Patient Age: 63 YR
• Patient Weight: 60