MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. EPTFE PATCHES; CARDIOVASCULAR PATCH

Catalog Number UNKNOWN

Device Problem Crack (1135)

Patient Problems Paralysis (1997); Aortic Dissection (2491); Iatrogenic Source (2498)

Event Date 11/28/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no images or photos have been made available to the manufacturer.Conclusion: the investigation is inconclusive, as no sample was returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: cardiovascular patches are not elastic.Care must be taken to cut the patches sufficiently large enough to eliminate anastomotic stresses.Exposure to solutions (e.G., alcohol, oil, aqueous solutions, etc.) may result in loss of the patch's hydrophobic properties.Loss of the hydrophobic barrier may result in patch wall leakage.Preclotting of this patch is unnecessary.Avoid excessive patch manipulation or pressure after exposure to blood or body fluids, as loss of the patch's hydrophobic properties may occur.Loss of the hydrophobic barrier may result in patch leakage.Adverse reactions: possible complications with the use of any cardiovascular patch include, but are not limited to: infection, thrombus formation, anastomotic blood leakage, peripatch seroma formation, pseudoaneurysm formation, and hematomas.Directions for use: sizing: it is critical that the patch be cut to the proper size for closure or repair.Cutting the patch too small increases the tension on the suture line which may result in elongated suture holes, thus causing increased suture line bleeding.Never suture two patches together to form a larger patch.This is not an accepted design criteria of the patch and may result in an inadequate repair or closure.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that approximately 36 days post aortic arch reconstruction, the patient was alleged to have required emergent surgery following aortic occlusion leading to dissection of the aorta.The aortic patch was described as having cracked.Additional surgeries 48 and 50 days post reconstruction were subsequently required; allegedly, due to surgical error and substandard post operative care.The patient now allegedly experiences flaccid paraparesis of the lower extremities with both cysto and neuroparalysis.

• Brand Name: EPTFE PATCHES
• Type of Device: CARDIOVASCULAR PATCH
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5680889
• MDR Text Key: 45956717
• Report Number: 2020394-2016-00469
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K905073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 12 YR