MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LIFESPAN EPTFE VASCULAR GRAFT; PROTHESIS, VASCULA GRAFT

Catalog Number R06030

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hematoma (1884)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

We have received a piece of the graft for evaluation.The graft was measured to be 7.5 cm in length.The graft had been used for av access for more than two months before it was explanted from the patient's vessel.Upon inspection of this graft, we observed multiple issues with the graft that might have led to the complications mentioned by the surgeon: 1.We observed multiple holes on both anterior and posterior section of the graft made by the cannulating needles during av access.This suggest that the cannulating needles used in this portion of the graft were inserted too deep into the graft and had punctured the posterior ends of the graft walls.The needle should be held at a 45- degree angle for the av grafts and the needles should not be advanced more than 1/8 of an inch.In this graft, the angle at which the needles were inserted was observed to be correct.However, the cannulating needles had inserted too deep perforating opposite section of the graft.Unfortunately, it is difficult to control back or sidewall bleeding because direct pressure to the puncture site is not possible.A severe infiltration, such as posterior or back wall infiltration in a ptfe graft can lead to the formation of the large hematoma and/or graft thrombosis as encountered in this graft.2.We also observed multiple puncture sites at close proximity to each other.Needles should be placed at least ¼ inch (6.35 mm) away from the last sites used.However, in this graft, we observed multiple puncture sites that are less than 3 mm apart.Proper-site rotation will extend the life span of the access by preventing psuedoaneurysm formation, or "one-site-itis".Grafts that are cannulated properly will not develop flat, mushy areas caused by repeated cannulation in the same spot, which do not allow for fibrous tissue formation and, subsequently, lead to the development of large holes.Grafts do not heal themselves.Over time, if a graft is stuck too often in the same small area, the vessel wall can weaken and tears the graft.This defect was also observed with this returned graft.Our review of the lot history record for this lot number did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Based on the documentation and complaint history review, we do not believe there is a systemic issue with these grafts.The root cause of this issue was determined to be improper cannulation technique by the medical staff during dialysis process.Our ifu properly describes all of the potential complications that may occur with the use of any vascular prosthesis including, but are not limited to excessive suture hole bleeding, thrombosis, thromboembolic complications; infection; ultrafiltration or perigraft seroma, swelling of limbs, pseudoaneurysms, perigraft hematomas, skin erosion, steal syndrome, preoperative hemorrhage, aortoenteric fistula.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.

Event Description

Lifespan eptfe polyester graft ( catalog#: r06030, lot#: lvg2407 ) was implanted on (b)(6) 2019 in the forearm of a hemodialysis patient for av access.The initial puncture was performed after 30-40 days allowing the graft to incorporate properly to its surrounding tissue.During cannulation, peri-prosthetic hematoma occured frequently as the graft was observed to be not adhering to its surrounding tissue.The graft was then explanted on (b)(6) 2019.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Type of Device: PROTHESIS, VASCULA GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC,; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 9297773
• MDR Text Key: 185477680
• Report Number: 1220948-2019-00149
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00840663105182
• UDI-Public: 00840663105182
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: R06030
• Device Lot Number: LVG2407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• 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): Required Intervention